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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsBone, Reproductive and Urologic Drugs AdComm

Meeting Date: 9/17/14-9/18/14

Meeting Details:

The committees will discuss the appropriate indicated population for testosterone replacement therapy and the potential for adverse cardiovascular outcomes associated with this use.

 

       
Location: College Park Marriott Hotel Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGDUFA Public Hearing on Policy Development

Meeting Date: 9/17/14-9/17/14

Meeting Details:

FDA is hosting the Generic Drug User Fee Amendments of 2012; Public Hearing on Policy Development to solicit public comment on certain topics related to implementation of GDUFA and the GDUFA Commitment Letter that accompanies the legislation. FDA wants your input on the five draft guidance documents FDA has issued or will issue shortly to facilitate implementation of GDUFA. FDA also seeks your input on additional policy priorities under GDUFA, such as the Agency’s consideration of generic drug exclusivity and the category of first generics. We will take the information from the public meeting into account in developing the fiscal year 2015 GDUFA priorities.

 

       
Location: College Park Marriott Hotel and Conference Center 3501 University Boulevard East Hyattsville, MD 20783 Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMethodological Considerations in Evaluation of Cancer

Meeting Date: 9/10/14-9/11/14

Meeting Details:

Methodological Considerations in Evaluation of Cancer as an Adverse Outcome Associated With Use of Non-Oncological Drugs and Biological Products in the Postapproval Setting; Public Meeting; Request for Comments The Food and Drug Administration (FDA), in collaboration with the National Cancer Institute (NCI), is announcing a public meeting entitled ‘‘Methodological Considerations in Evaluation of Cancer as an Adverse Outcome Associated With Use of Non-Oncological Drugs and Biological Products in the Postapproval Setting.’’ The purpose of the public meeting is to engage in constructive dialogue and information sharing among regulators, researchers, the pharmaceutical industry, public health agencies, health care providers, and the general public concerning challenges in designing and implementing postapproval studies to evaluate the risk of cancer associated with use of non-oncological drugs and biological products. The input from this meeting and public docket will be used to inform the Agency on best study design and methodological options to consider when evaluating cancer risk in the postapproval setting.

 

       
Location: The DoubleTree by Hilton Hotel Washington DC—Silver Spring The Pinnacle Grand Ballroom 8727 Colesville Road Silver Spring, MD 20910 Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsConfidentiality of Interim Results in Cardiovascular Outcome Safety Trials

Meeting Date: 8/11/14-8/11/14

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public hearing that will provide a forum to discuss confidentiality of interim results for certain cardiovascular outcomes trials (CVOTs) submitted to the Agency while the trials are still ongoing. The purpose of the public hearing is to initiate constructive discussion among regulators, researchers, health care providers, representatives from the pharmaceutical industry and health care organizations, and the general public, about appropriate handling of interim analysis results of these ongoing CVOTs. FDA is also opening a public docket to receive comments on this topic.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Analgesic Drug Products

Meeting Date: 6/11/14-6/12/14

Meeting Details:

The committee will discuss the potential cardiovascular risk associated with products in the class of peripherally acting opioid receptor antagonists and the necessity, timing, design, and size of cardiovascular outcomes trials to support approval of products in the class for the proposed indication of opioid-induced constipation in patients taking opioids for chronic pain.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMedical Devices Dispute Resolution Panel

Meeting Date: 6/10/14-6/10/14

Meeting Details:

Oxiplex®/SP Gel; FzioMed, Incorporated’s Petition for Review of the Food and Drug Administration’s Denial of Premarket Approval.

 

       
Location: Hilton Washington DC/North Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMolecular and Clinical Genetics Panel

Meeting Date: 3/26/14-3/27/14

Meeting Details:

On March 26, 2014, the committee will discuss, make recommendations and vote on information related to the premarket approval application sponsored by Epigenomics, Inc. for the Epi proColon. The Epi proColon test is a qualitative in vitro diagnostic method for the detection of methylated Septin 9 DNA in plasma derived from patient whole blood specimens. Methylation of the target Septin 9 DNA sequence has been associated with the occurrence of colorectal cancer (CRC). The test is indicated to screen patients for CRC who are defined as average risk for CRC by current screening guidelines. The Epi proColon test is not intended to replace colorectal screening by colonoscopy. Patients with a positive Epi proColon test result should be referred for diagnostic colonoscopy. The Epi proColon test results are intended to be used in conjunction with the physician's assessment of history, other risk factors, and professional guidelines. On March 27, 2014, the committee will discuss, make recommendations and vote on information related to the premarket approval application for the Cologuard device, sponsored by Exact Sciences. Cologuard is an in vitro diagnostic device designed to analyze patients' stool for detection of hemoglobin, multiple DNA methylation and mutational markers, and the total amount of human DNA. Cologuard is intended for use as an adjunctive screening test for the detection of colorectal neoplasia associated DNA markers and for the presence of occult hemoglobin in human stool. A positive result may indicate the presence of colorectal cancer or premalignant colorectal neoplasia. Cologuard is not intended as a replacement for colonoscopy. Cologuard is intended to be used in conjunction with colonoscopy and other test methods in accordance with recognized screening guidelines.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsDevice Good Manufacturing Practice AdComm

Meeting Date: 4/11/13-4/11/13

Meeting Details:

On April 11, 2013, the committee will discuss the potential effects of extreme weather and natural disasters on medical device manufacturing chain processes and marketed medical device safety and quality. The committee will further discuss how to optimize the use of FDA's current regulatory framework to address risks and vulnerabilities to the manufacturing chain resulting from extreme weather conditions. Future steps may be identified to help industry mitigate or better tolerate challenges to the manufacturing chain as a result of extreme weather conditions. In a separate Federal Register notice, FDA is seeking additional broad public input about the effects of extreme weather on medical device safety and quality.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPublic Workshop: Innovations in Breast Cancer Drug Development–Neoadjuvant Breast Cancer Workshop

Meeting Date: 3/22/13-3/22/13

Meeting Details:

This workshop will provide a forum to discuss issues related to breast cancer drug development in the neo-adjuvant setting. The topics will include: (1) how Neoadjuvant trials can expedite drug development, (2) the Collaborative Trials in Neoadjuvant Breast Cancer (CTNeoBC) meta-analysis results, and (3) the draft FDA Guidance for Industry: Use of Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Early Stage Breast Cancer as an Endpoint to Support Accelerated Approval. The discussions at this workshop will be taken into consideration as the FDA moves to finalize the Draft Guidance for Industry - Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPublic Workshop on Minimal Residual Disease

Meeting Date: 3/4/13-3/4/13

Meeting Details:

The Food and Drug Administration (FDA), in cosponsorship with the American Society of Clinical Oncology, is announcing a public workshop that will provide a forum for discussion of extending the qualification of minimal residual disease (MRD) detection as a prognostic biomarker to an efficacy/response biomarker in evaluating new drugs for the treatment of acute myeloid leukemia (AML). Our objective is for the workshop to provide a venue for an in-depth discussion of potential endpoints for trials intended to support the approval of new drugs or biologics for treatment of AML. Participants in the workshop will examine if any currently used biomarker can be used as a surrogate endpoint, identify the preferred technology platform and performance characteristics for the assay of the biomarker, discuss any issues regarding ongoing deficiencies in methodological standardization for the biomarker, and determine the need for additional FDA-approved in-vitro diagnostics for AML drug development. The primary focus will be on the biomarkers that are or will soon be ready for incorporation into clinical trials, and the technical and regulatory challenges for use of these markers.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPublic Workshop on Minimal Residual Disease

Meeting Date: 2/27/13-2/27/13

Meeting Details:

The Food and Drug Administration (FDA), in cosponsorship with the American Society of Clinical Oncology, is announcing a public workshop that will provide a forum for discussion of extending the qualification of minimal residual disease (MRD) detection as a prognostic biomarker to that of an efficacy/response biomarker in evaluating new drugs for the treatment of chronic lymphocytic leukemia (CLL). Our objective for the workshop is to provide a venue for an in-depth discussion of potential surrogate endpoints for trials intended to support the approval of new drugs or biologics for the treatment of CLL. Participants in the workshop will examine the advantages and disadvantages of MRD as a surrogate endpoint for approval, identify the preferred technology platform and performance characteristics for the assay of this biomarker, and discuss any issues regarding methodological standardization for the biomarker. The primary focus will be on the biomarkers that are ready for incorporation into clinical trials and the technical and regulatory challenges for use of these markers.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsImpact of Approved Drug Labeling on Chronic Opioid Therapy

Meeting Date: 2/7/13-2/8/13

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public hearing to obtain information, particularly scientific evidence, such as study data or peer-reviewed analyses, on issues pertaining to the use of opioid drugs in the treatment of chronic pain.

 

       
Location: Bethesda Marriott 5151 Pooks Hill Road Bethesda, Maryland 20814 Related News Links: Not Available
Time: 9:00AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPublic Hearing Unmet Medical Need

Meeting Date: 2/4/13-2/5/13

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public hearing to obtain input on a potential new pathway to expedite the development of drugs, including biological products, for serious or lifethreatening conditions that would address an unmet medical need. The drug’s safety and effectiveness would be studied in a smaller subpopulation of patients with more serious manifestations of a condition. Such a pathway could involve smaller and more rapid clinical trials than would occur if the drug were studied in a broader group of patients with a wide range of clinical manifestations. The labeling of drugs approved using this pathway would make clear that the drug is narrowly indicated for use in limited, well-defined subpopulations in which the drug’s benefits have been shown to outweigh its risks. The purpose of the public hearing is to obtain information and comments from the public on the need for and feasibility of this pathway and its potential advantages and disadvantages.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 9:00AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsAntibacterial Drugs for the Treatment of Non-Cystic Fibrosis Bronchiectasis

Meeting Date: 9/7/12-9/7/12

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public workshop focusing on the design of clinical trials of antibacterial drugs for the treatment of non-cystic fibrosis (non-CF) bronchiectasis. This public workshop is intended to provide information for, and gain perspective from, health care providers, patients and patient advocacy organizations, academia, and industry on various aspects of the design of clinical trials. The input from this public workshop will useful in developing topics for further discussion.

 

       
Location: Sheraton Silver Spring Hotel Related News Links: Not Available
Time: 8:00AM-3:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsAssessment of Analgesic Treatment of Chronic Pain--A Public Workshop

Meeting Date: 5/30/12-5/31/12

Meeting Details:

The purpose of the meeting is to provide a forum to discuss the available data on the use of analgesics in the treatment of CNCP, beginning with a discussion of the underlying mechanisms of chronic pain and the epidemiology of chronic pain in the United States. Next, data on the efficacy of opioids and other analgesics in the treatment of chronic pain from a variety of sources will be reviewed. Those sources will include randomized controlled trials, epidemiological studies, case series and other types of studies. Patient and clinician perspectives on the pharmaceutical treatment of CNCP will be presented by people living with chronic pain and those who treat or care for patients with chronic pain. Finally, a general assessment of the available data and discussion of future research needs and next steps will be used to inform future actions that can help guide appropriate therapy for patients with CNCP.

 

       
Location: Natcher Auditorium, Natcher Conference Center, National Institutes of Health Campus, 45 Center Dr., Bethesda, MD 20892 Related News Links: Not Available
Time: 8:00AM-5:15PM    
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Meeting OptionsMeeting OptionsMeeting OptionsDevelopment of Biosimilar Products; Public Hearing

Meeting Date: 5/11/12-5/11/12

Meeting Details:

The Food and Drug Administration (FDA) is announcing a 1-day public hearing to obtain input on recently issued draft guidances relating to the development of biosimilar products (draft guidances). These draft guidances were issued by FDA as part of the implementation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The BPCI Act establishes an abbreviated licensure pathway for biological products that are demonstrated to be biosimilar to, or interchangeable with, a reference product. FDA will consider the information it obtains from the public hearing in the finalization of these guidances. In addition, FDA is soliciting public input regarding topics for future policies regarding biosimilars.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:30AM-5:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsBiosimilar: Biologics Price Competition and Innovation Act of 2009

Meeting Date: 12/16/11-12/16/11

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public meeting to discuss the proposed recommendations for a user fee program for biosimilar biological products for fiscal years (FYs) 2013 through 2017.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 9:00AM-1:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPublic Workshop: Center for Drug Evaluation and Research, Approach to Addressing Drug Shortage

Meeting Date: 9/26/11-9/26/11

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public workshop regarding the approach of the Center for Drug Evaluation and Research (CDER) to addressing drug shortages. This public workshop is intended to provide information for, and to gain additional insight from, professional societies, patient advocates, industry, consumer groups, health care professionals, researchers, and other interested persons about the causes and impact of drug shortages, and possible strategies for preventing or mitigating drug shortages. The input from this public workshop will help in developing topics for further discussion with industry and professional societies, and other stakeholders and may help the Agency to better address drug shortage issues.

 

       
Location: 10903 New Hampshire Avenue Bldg. 31, Room 1503 B and C (Great Room) Silver Spring, MD 20993 Related News Links: Not Available
Time: 8:00AM-4:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsCellular, Tissue and Gene Therapies AdComm

Meeting Date: 6/29/11-6/29/11

Meeting Details:

On June 29, 2011, the committee will discuss cellular and gene therapy products for the treatment of retinal disorders. Topics to be considered include the following: (1) Efficacy endpoints in pediatric and adult populations, (2) potential safety issues related to repeat administration or second eye administration, and (3) evaluation of product delivery into target site.

 

       
Location: Crowne Plaza Hotel - Silver Spring, MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsFDA / Genentech (Avastin) Public Hearing

Meeting Date: 6/28/11-6/29/11

Meeting Details:

The Food and Drug Administration (FDA) is granting a hearing to Genentech, Inc. (Genentech), on the Center for Drug Evaluation and Research's (CDER's) proposal to withdraw approval of the breast cancer indication for bevacizumab (Avastin). Genentech is the sponsor for Avastin. Genentech and CDER are the parties to the hearing. The issues to be discussed and resolved at the hearing relate directly to the statutory and regulatory standard for FDA to withdraw accelerated approval of the metastatic breast cancer (MBC or breast cancer) indication for Avastin.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsSafety and Efficacy of Hypnotic Drugs

Meeting Date: 5/10/11-5/11/11

Meeting Details:

The Division of Neurology Products of the U.S. Food and Drug Administration (FDA), in conjunction with the Pharmaceutical Education Research Institute (PERI), is holding a two-day expert panel workshop on the safety and efficacy evaluation of hypnotic drugs.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMolecular and Clinical Genetics Panel

Meeting Date: 3/8/11-3/9/11

Meeting Details:

On March 8 and 9, 2011, the committee will discuss and make recommendations on scientific issues concerning direct to consumer (DTC) genetic tests that make medical claims. The scientific issues to be discussed include: (1) The risks and benefits of making clinical genetic tests available for direct access by a consumer without the involvement of a clinician (i.e., without a prescription). The discussion will include consideration of the benefits and risks of direct access for different tests or categories of tests that would support differences in the regulatory approach. Clinical genetic test categories that have been proposed to be offered directly to consumers include: (a) Genetic carrier screening for hereditary diseases (e.g., cystic fibrosis carrier screening); (b) Genetic tests to predict risk for future development of disease, in currently healthy persons (e.g., tests to predict risk of developing breast or ovarian cancer); and (c) Genetic tests for treatment response prediction (e.g., tests to predict whether individual will respond to a specific drug). (2) The risks of and possible mitigations for incorrect, miscommunicated, or misunderstood test results for clinical genetic tests that might be beneficial if offered through direct access testing. (3) The level and type of scientific evidence appropriate for supporting direct-toconsumer genetic testing claims including whether it should be different than that required to support similar claims for prescription use clinical genetic tests.

 

       
Location: Holiday Inn Gaithersburg, MD. Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsRisks and Benefits of Long-Term Use of Nicotine Replacement Therapy

Meeting Date: 10/26/10-10/27/10

Meeting Details:

The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) is announcing a scientific workshop that will focus on the risks and benefits associated with the long-term use of nicotine replacement therapy (NRT) products. NRT products facilitate smoking cessation by ameliorating the symptoms of nicotine withdrawal and are available as approved nonprescription and prescription drugs. No currently approved NRT product is intended for use beyond 12 weeks to relieve the acute withdrawal symptoms experienced when quitting smoking.

 

       
Location: Radisson Hotel Arlington, VA 22202 Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPublic Meeting: Cystic Fibrosis

Meeting Date: 9/23/10-9/24/10

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public workshop regarding scientific issues in clinical development of aerosolized antimicrobials for the management and/or treatment of patients with cystic fibrosis. Aerosolized antimicrobials are used to treat chronic bacterial infection in the lungs and thus improve the respiratory symptoms in patients with cystic fibrosis. This public workshop is intended to provide information for and gain perspective from health care providers, patients and patient advocacy organizations, academia, and industry on various aspects of the design of clinical trials of aerosolized antimicrobials in patients with cystic fibrosis. The input from this public workshop will help in developing topics for further discussion.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneric Drug User Fee

Meeting Date: 9/17/10-9/17/10

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public meeting to gather stakeholder input on the development of a generic drug user fee program. The number of human generic drug applications awaiting FDA action and the median review times for generic drug applications have increased in recent years. A user fee program could provide necessary supplemental funding, in addition to current Congressional appropriations, to allow for the timely review of such applications. Although the President's Fiscal Year (FY) 2011 budget includes generic drug user fees, new legislation would be required for FDA to establish and collect user fees under such a program. As FDA begins negotiations with the regulated industry about generic drug user fees, FDA will hold a public meeting to gather the public's input on such a program.

 

       
Location: Hilton Rockville, MD 20852. Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsIssues in the Design and Conduct of Clinical Trials for Antibacterial Drug Development

Meeting Date: 8/2/10-8/3/10

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public workshop regarding scientific issues in the design and conduct of clinical trials for antibacterial drug development. The public workshop is intended to provide information for and gain perspectives from health care providers, researchers, academia, industry, and regulators on various aspects of design and conduct of clinical trials for antibacterial drugs. The workshop will focus on the design and conduct of non-inferiority (NI) clinical trials, which are often used in the evaluation of the safety and efficacy of a new antibacterial drug. The input from this public workshop will help in developing topics for further discussion.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPublic Workshop: Antibody Mediated Rejection

Meeting Date: 6/28/10-6/29/10

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public workshop regarding scientific issues in clinical development of medical products (i.e., human drugs, therapeutic biological products, and medical devices) for prophylaxis and/or treatment of acute antibody mediated rejection (AMR) in kidney transplant recipients. This public workshop is intended to provide information for and gain perspective from health care providers, academia, and industry on various aspects of development of medical products for prophylaxis and/or treatment of acute AMR in kidney transplant recipients, including clinical trial design and endpoints. The input from this public workshop will help in developing topics for further discussion.

 

       
Location: FDA Meeting Room Crowne Plaza Hotel Silver Spring, MD Related News Links: Not Available
Time: 8:00AM-6:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsDeveloping Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors

Meeting Date: 6/24/10-6/25/10

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public workshop entitled “Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors” to initiate dialogue and share information about the design of drug and therapeutic biologic container labels, carton labeling, and product packaging, and practices to develop testing of proprietary names to reduce medication errors. The input from this workshop will be used to develop draft guidance for industry in these areas to reduce medication errors. A public docket [FDA-2010-N-0168-0001] is open until July 23, 2010 to receive comments on this topic.

 

       
Location: Marriott Residence Inn Bethesda, MD 20814 Related News Links: Not Available
Time: 8:30AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsInfusion Pumps

Meeting Date: 5/25/10-5/26/10

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public meeting regarding external infusion pumps. The purpose of the meeting is to inform the public about current problems associated with external infusion pump use, to help the agency identify quality assurance strategies to mitigate these problems, and to solicit comments and input regarding how to bring more effective external infusion pumps to market. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft guidnace document entitled ``Total Product Life Cycle: Infusion Pump--Premarket Notification (510(k)) Submissions.''

 

       
Location: Hilton Silver Spring MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsFDA Hearing on HCV Oral Drugs Early Access

Meeting Date: 4/30/10-4/30/10

Meeting Details:

The Food and Drug Administration (FDA or the agency) is announcing a public hearing to obtain input on the scope and implementation of potential expanded access programs with direct-acting antiviral agents (DAAs) for the treatment of chronic hepatitis C (CHC) infection in patients with unmet medical need. This public hearing is being held to obtain comments from the public on eligibility criteria that should be used for patient enrollment in expanded access protocols involving DAAs and to elicit suggestions for designs of protocols for treatment investigational new drug applications (INDs) involving DAAs and other expanded access protocols. In addition, the agency would like public input on types of studies that should be conducted to obtain information on patients with unmet medical need including those with the greatest risk of progression of liver disease and/or the lowest predicted virologic response rates.

 

       
Location: Hilton Hotel Rockville, MD 20852 Related News Links: Not Available
Time: 9:00AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPrescription Drug User Fee Act;

Meeting Date: 4/12/10-4/12/10

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public meeting on the Prescription Drug User Fee Act (PDUFA). The legislative authority for PDUFA expires in September 2012. At that time, new legislation will be required for FDA to continue collecting user fees for the prescription drug program. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that before FDA begins negotiations with the regulated industry on PDUFA reauthorization, we publish a notice in the Federal Register requesting public input on the reauthorization, hold a public meeting at which the public may present its views on the reauthorization, provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes, and publish the comments on FDA’s Web site. FDA invites public comment on the PDUFA program and suggestions regarding the features FDA should propose for the next PDUFA program.

 

       
Location: Hilton Rockville MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsBlood Glucose Meters

Meeting Date: 3/16/10-3/17/10

Meeting Details:

This public meeting is intended to raise public awareness about the accuracy and clinical use of blood glucose meters, to share ideas on the challenges associated with their use, to seek public comments on this topic and to work towards identifying solutions. The input from this public workshop will help to determine the appropriate performance standards for point of care blood glucose meters.

 

       
Location: Maryland Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPromotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools

Meeting Date: 11/12/09-11/13/09

Meeting Details:

The Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research (CDER), in collaboration with FDA's Center for Biologics Evaluation and Research (CBER), Center for Veterinary Medicine (CVM), and Center for Devices and Radiological Health (CDRH), is announcing a public hearing to discuss issues related to the promotion of FDA-regulated medical products (including prescription drugs for humans and animals, prescription biologics, and medical devices) using the Internet and social media tools. FDA is seeking participation in the public hearing and written comments from all interested parties, including, but not limited to, consumers, patients, caregivers, health care professionals, patient groups, Internet vendors, advertising agencies, and the regulated industry. This meeting and the written comments are intended to help guide FDA in making policy decisions on the promotion of human and animal prescription drugs and biologics and medical devices using the Internet and social media tools. FDA is seeking input on a number of specific questions but is interested in any other pertinent information participants in the hearing would like to share.

 

       
Location: NTSB Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsFDA Pediatric Clinical Trials Workshop

Meeting Date: 10/29/09-10/30/09

Meeting Details:

This public workshop is intended to solicit information about and gain perspective from health care providers, academia, and industry on various aspects of clinical trials involving pediatric diseases and patients. Specialty Discussion topics include: Pediatric Musculoskeletal Disease Pediatric Cardiovascular Disease Pediatric Abdominal and GI diseases Pediatric Neurologic Disorders Pediatric Genitourinary Diseases Pediatric Speech and Audiologic Disorders and Diagnostics for pediatric patients: Challenges

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-5:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsIssues in the Design of Clinical Trials of Antimycobacterial Drugs for Treatment of Tuberculosis

Meeting Date: 7/30/09-7/31/09

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public workshop regarding scientific issues in clinical trial design for the treatment of tuberculosis. This public workshop is intended to bring together public health experts, health care providers, academia, and industry to share perspectives on scientific aspects of antimicrobial drug development for tuberculosis. Topics will include considerations in the development of clinical trials to study treatments for tuberculosis, including enrollment of patients, the effect of antimicrobial treatment, study endpoints, and statistical issues in analysis of results. The input from this public workshop will help in developing topics for further public discussion.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Drug Safety and Risk Mgmt, OTC Drugs, & Anesthetic and Life Support Drugs AdComms

Meeting Date: 6/29/09-6/30/09

Meeting Details:

The primary topic area for discussion is how to address the public health problem of liver injury related to the use of acetaminophen in both over-the-counter (OTC) and prescription (Rx) products. FDA recognizes that acetaminophen is an important drug used to treat pain and fever in both settings and is not seeking to remove it from the market. The risk of developing liver injury to the individual patient who uses the drug according to directions is very low. However, acetaminophen containing products are used extensively making the absolute number of liver injury cases a public health concern.

 

       
Location: Marriott Conference Centers Adelphi, MD. Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsFDA Transparency Task Force

Meeting Date: 6/24/09-6/24/09

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public meeting to solicit recommendations from interested persons on ways in which FDA can make useful and understandable information about FDA activities and decision making more readily available to the public.

 

       
Location: NTSB Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsRisk Evaluation and Mitigation Strategies for Certain Opioid

Meeting Date: 5/27/09-5/28/09

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public meeting to obtain input on developing Risk Evaluation and Mitigation Strategies (REMS) for certain opioid drugs. The REMS would be intended to ensure that the benefits of these drugs continue to outweigh certain risks. The agency has long been concerned about adverse events associated with this class of drug and has taken steps in cooperation with drug manufacturers to address these risks. We intend to use the agency's REMS authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA) to mitigate the risks of these drugs. The purpose of the public meeting is to receive information and comments on this topic.

 

       
Location: TBA Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsClinical Trial Design for HAP and VAP

Meeting Date: 3/31/09-4/1/09

Meeting Details:

This public workshop is intended to provide information for and gain perspective from health care providers, academia, and industry on various aspects of antimicrobial drug development for HAP and VAP, including diagnosis of HAP and VAP, effect of antimicrobial treatment for HAP and VAP, endpoints for trials of HAP and VAP, and statistical issues in analysis of results of trials in HAP and VAP. The input from this public workshop will help in developing topics for further discussion.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsRisk Communication AdComm

Meeting Date: 2/26/09-2/27/09

Meeting Details:

On February 26 and 27, 2009, there will be a discussion of different types of prescription drug information currently available to patients in the form of Medication Guides, Patient Package Inserts (PPIs), and Consumer Medication Information (CMI).

 

       
Location: NTSB Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsOver the Counter Cough and Cold Medications

Meeting Date: 10/2/08-10/2/08

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public hearing to obtain input regarding over-the-counter (OTC) cough and cold drugs marketed for pediatric use. Many of these nonprescription cough and cold drug products are marketed under the OTC Drug Review, which established a monograph describing the conditions under which certain OTC ingredients are considered to be generally recognized as safe and effective. Recently, safety and efficacy concerns have been raised regarding the pediatric dosing and use of certain active ingredients in OTC cough and cold drug products. FDA is developing a proposed rule to revise the pediatric labeling contained in the Final Monograph for Cough, Cold, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use. At this public hearing, FDA is interested in obtaining public comment about certain scientific, regulatory, and product use issues as it proceeds with the rulemaking and reviews new drug applications (NDAs) for these ingredients.

 

       
Location: Sheraton Washington North Hotel 4095 Powder Mill Rd. Beltsville, MD 20705. Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsRisk Communication AdComm

Meeting Date: 8/14/08-8/15/08

Meeting Details:

On August 14 and 15, 2008, the committee will meet for presentations and discussion of the scientific basis for translating principles of risk communication into practice in situations of emerging and uncertain risk.

 

       
Location: FDA Meeting Room Rockville, MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting for Public Comment Pilot Program to Evaluate Proposed Name Submissions

Meeting Date: 6/5/08-6/6/08

Meeting Details:

The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA) are announcing a public technical meeting in preparation for a pilot program to enable pharmaceutical firms to evaluate proposed propriety names and submit the data generated from those evaluations to FDA for review. The purpose of the public technical meeting is to discuss a concept paper that describes the logistics of the pilot program, proposed recommendations for carrying out a proprietary name review, and the way FDA intends to review submissions made under the pilot program. FDA plans to formally issue the concept paper by the end of fiscal year (FY) 2008 and expects to begin enrollment in the pilot program in FY 2009.

 

       
Location: Crowne Plaza Hotel Silver Spring, MD Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsRisk Communication Advisory Committee

Meeting Date: 5/15/08-5/16/08

Meeting Details:

On May 15, 2008, the committee will meet for presentations and discussion of direct-to-consumer (DTC) advertising, including how it relates to communicating to subsets of the general population, such as the elderly, children, and racial and ethnic minority communities, and increased access to health information and decreased health disparities for these populations. On May 16, 2008, the committee will discuss studying the appropriateness of including, in televised DTC ads, a statement encouraging consumers to report negative side effects of prescription drugs to MedWatch, as is currently required for print DTC prescription drug ads.

 

       
Location: Hilton Rockville MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPharmacoepidemiologic Safety Studies

Meeting Date: 5/7/08-5/7/08

Meeting Details:

The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA) are announcing a public workshop entitled ‘‘Developing Guidance on Conducting Scientifically Sound Pharmacoepidemiologic Safety Studies Using Large Electronic Healthcare Data Sets.’’ The purpose of the public workshop is to solicit information and views from interested persons on best practices and principles for the design and evaluation of pharmacoepidemiologic safety studies using large electronic healthcare data sets. The input from this workshop will be used to develop a draft Guidance to Industry, and to provide consistent review criteria for FDA to use in evaluating protocols and study reports submitted to the agency. DATES: The public workshop will be held on Wednesday, May 7, 2008, from 8:30 a.m. to 5 p.m. See section III of this document for information on the deadline and on how to attend or present at the meeting. Written or electronic comments must be submitted to the docket by June 7, 2008.

 

       
Location: Hilton Silver Spring MD Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting Options(HBOCs)Safety of Hemoglobin-Based Oxygen Carriers

Meeting Date: 4/29/08-4/30/08

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public workshop entitled: "Hemoglobin Based Oxygen Carriers: Current Status and Future Directions." The purpose of the public workshop is to discuss the safety of hemoglobin-based oxygen carriers (HBOCs) as related to a variety of potential uses of these investigational products. We are having this discussion because clinical and nonclinical studies of HBOCs, as either blood substitutes or as resuscitation fluids, have raised questions about the safety of these products as a group. The public workshop will feature presentations and roundtable discussions led by experts from academic institutions, government, and industry. Topics to be discussed include oxygen and nitric oxide physiology in relation to hemoglobin and HBOCs in general and an overview of the biochemical and physiological aspects of HBOCs with special emphasis on the strengths and limitations of animal studies. The workshop will feature presentations by manufacturers of HBOCs on their experiences gained in the course of development of these products. Roundtable discussions by experts in different disciplines will focus on organ specific adverse effects seen with a variety of HBOCs and potential underlying mechanisms. The workshop will conclude with presentations on finding ways forward in terms of biochemical mitigation strategies, animal studies and alternative focused clinical designs.

 

       
Location: Natcher Conference Center Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAntimicrobial Resistance

Meeting Date: 4/28/08-4/28/08

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public hearing on antimicrobial resistance. FDA is seeking general information about the problem of antimicrobial resistance, recommendations as to possible approaches to contain the problem of antimicrobial resistance, responses to specific questions (see section III of this document), and other pertinent information from interested parties. In addition, interested parties may provide views on which serious and life-threatening infectious diseases, such as diseases due to gram-negative bacteria and other diseases due to antimicrobial-resistant bacteria, potentially qualify for available grants and contracts or other development incentives.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsRisk Communication Advisory Committee

Meeting Date: 2/28/08-2/29/08

Meeting Details:

On February 28,2008, the committee will meet for the first time, for presentations and discussion of the relation of FDA's risk communication programs and FDA's responsibilities. On February 29, 2008, FDALive will continue with presentations and discussion of FDA's proposed template for press releases announcing product recalls with a view to incorporating best practices of risk communication.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsClinical Trial Design for Community-Acquired Pneumonia

Meeting Date: 1/17/08-1/18/08

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public workshop, cosponsored with the Infectious Diseases Society of America(IDSA), regarding scientific issues in clinical trial design for community-acquired pneumonia. This public workshop is intended to provide information for and to gain perspective from health care providers, academia, and industry on various aspects of antimicrobial drug development for community-acquired pneumonia, including diagnosis of community-acquired pneumonia, effect of antimicrobial treatment for community-acquired pneumonia, endpoints for trials of community-acquired pneumonia, and statistical issues in analysis of results of trials in community-acquired pneumonia. The input from this public workshop will help in developing topics for further discussion.

 

       
Location: Crowne Plaza Hotel, Kennedy Room 8777 Georgia Avenue Silver Spring, MD 20910 Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsBehind the Counter Availability of Certain Drugs

Meeting Date: 11/14/07-11/14/07

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public meeting to obtain comments regarding behind-the-counter (BTC) availability of drugs. Currently, drugs are available as prescription and non-prescription. Generally, non-prescription products are available in an ``over-the-counter'' (OTC) manner.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsUse of Ozone-Depleting Substances

Meeting Date: 8/2/07-8/2/07

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public meeting to solicit comments on a proposed rule that would amend FDA's regulation on the use of ozone-depleting substances (ODSs) in self-pressurized containers to remove essential-use designations for certain oral pressurized metered-dose inhalers (MDIs). In the Federal Register of June 11, 2007 (72 FR 32030), the agency proposed to remove the essential use designation for MDIs containing flunisolide, triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in combination, cromolyn, and nedocromil. Information from the public meeting, which is required by agency regulations, will be considered in finalizing the rulemaking.

 

       
Location: TBA Related News Links: Not Available
Time: 9:00AM-3:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsRiskMAPs

Meeting Date: 6/25/07-6/26/07

Meeting Details:

Implementation of Risk Minimization Action Plans (RiskMAPs) to Support Quality Use of Pharmaceuticals: Opportunities and Challenges; Public Workshop - The Agency for Healthcare Research and Quality (AHRQ) and the Food and Drug Administration (FDA) are announcing a 2-day joint public workshop entitled ``Implementation of Risk Minimization Action Plans (RiskMAPs) to Support Quality Use of Pharmaceuticals: Opportunities and Challenges.'' This public workshop is intended to seek constructive input from a wide range of stakeholders, including clinicians, pharmacists, patients, third party payers of care, the pharmaceutical and biotechnology industries, researchers, and innovators in health information technology (HIT), to help in the development and implementation of mechanisms to minimize the risks of pharmaceuticals with unusual safety and patient monitoring concerns. This meeting is an initial step that is part of FDA's commitment to monitor the performance of RiskMAPs consistent with the goal articulated in the proposed PDUFA IV agreement to undertake regular follow up of these plans.

 

       
Location: TBA Related News Links: Not Available
Time: 8:30AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsUse of Medication Guides to Distribute Drug Risk Information to Patients

Meeting Date: 6/12/07-6/13/07

Meeting Details:

On June 12-13, 2007, FDA’s Center for Drug Evaluation and Research (CDER) will hold a public hearing to obtain feedback on FDA’s Medication Guide program, which provides for the distribution of FDA-approved written patient information for certain drug and biological products that pose serious and significant public health concerns. FDA is interested in obtaining public comment on ways to improve communication to patients who receive Medication Guides. The purpose of the public hearing is to solicit information and views from interested persons on specific issues associated with the development, distribution, comprehensibility, and accessibility of Medication Guides, which are required to convey risk information to patients.

 

       
Location: Hilton Silver Spring Related News Links: Not Available
Time: 8:30AM-4:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsElectronic Distribution of Prescribing Information for Prescription Drug Products

Meeting Date: 4/27/07-4/27/07

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public hearing to solicit views and information from interested parties concerning the concept of electronic distribution of FDA-approved prescribing information currently contained in the package insert (or PIs) for human prescription drug and biological products. In particular, FDA is seeking views and information on the feasibility of establishing a modern and efficient process for industry to electronically distribute prescribing information to dispensers. We are seeking input on a number of questions regarding the current use of package inserts and those logistical issues associated with electronic distribution of such prescribing information.

 

       
Location: TBA Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMedical Devices Dispute Resolution Panel

Meeting Date: 4/19/07-4/19/07

Meeting Details:

The committee will discuss, make recommendations, and vote regarding a scientific dispute between the agency and Cardima Inc. related to the not-approvable determination for the premarket approval application (PMA) for the REVELATION Tx Microcatheter with NavAblator Ablation System, indicated for the treatment of drug refractory paroxysmal atrial fibrillation.

 

       
Location: Holiday Inn Gaithersburg, MD Related News Links: Not Available
Time: 8:30AM-5:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsSentinel Network To Promote Medical Product Safety

Meeting Date: 3/7/07-3/8/07

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public meeting to explore opportunities to link private sector and public sector postmarket safety efforts to create a virtual, integrated, electronic ``Sentinel Network.'' Such a network would integrate existing and planned efforts to collect, analyze, and disseminate medical product safety information to health care practitioners and patients at the point-of-care. It would be established through multiple, broad-based, public-private partnerships. We are seeking input on a number of specific questions regarding opportunities for collaboration, the efficient use of information technology, and the collection and analysis of medical product safety information.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPDUFA - Prescription Drug User Fee Act

Meeting Date: 2/16/07-2/16/07

Meeting Details:

The Food and Drug Administration (FDA, we) is publishing proposed recommendations for the reauthorization of the Prescription Drug User Fee program for the process of human drug application review for fiscal years (FY) 2008 to 2012. These proposed recommendations were developed after discussions with regulated industry and consultation with appropriate scientific and academic experts, healthcare professionals, and representatives of patient and consumer advocacy groups. Section 505 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, enacted June 12, 2002, directs FDA to publish these proposed recommendations in the Federal Register; hold a meeting at which the public may present its views on such recommendations; and provide for a period of 30 days for the public to provide written comments on such recommendations.

 

       
Location: TBA Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsIn Vitro Diagnostic Multivariate Index Assays

Meeting Date: 2/8/07-2/8/07

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public meeting on In Vitro Diagnostic Multivariate Index Assays. The meeting is intended to provide a public forum during which FDA will hear presentations and comments from interested stakeholders regarding the draft guidance entitled ``Draft Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays.'' This draft guidance is intended to provide clarification on FDA's approach to regulation of in vitro diagnostic multivariate index assays. FDA is seeking comments on this draft guidance.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsSupplements and Other Changes to an Approved Application

Meeting Date: 2/7/07-2/7/07

Meeting Details:

FDA is announcing a public meeting to solicit comments on issues that FDA should consider when developing revisions to its regulations regarding chemistry, manufacturing, and controls (CMC) supplements and other changes to approved marketing applications for human drugs.

 

       
Location: TBA Related News Links: Not Available
Time: 8:30AM-3:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMedical Devices Dispute Resolution Panel

Meeting Date: 1/15/07-1/15/07

Meeting Details:

The committee will discuss, make recommendations, and vote regarding a scientific dispute between the agency and Acorn Corporation related to the approvability of a premarket approval application for the CorCap Cardiac Support Device for patients with dilated cardiomyopathy.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsImproving Patient Safety

Meeting Date: 1/11/07-1/11/07

Meeting Details:

Public Meeting on Improving Patient Safety by Enhancing the Container Labeling for Parenteral Infusion Drug Products - On January 11, 2007, FDA’s Center for Drug Evaluation and Research (CDER) will hold a public meeting on improving patient safety by enhancing the container labeling for parenteral infusion drug products. This will be a 1-day workshop involving FDA staff and representatives of the United States Pharmacopeia (USP) and the Institute for Safe Medication Practices (ISMP). The purpose of the meeting is to explore how labels on intravenous (IV) drug products could be designed to minimize medication errors. Design issues include placement, style and type of information, the need for standard expression of strength, quantity of information, and use of color on the label.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-4:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMarketed Unapproved Drugs

Meeting Date: 1/9/07-1/9/07

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public workshop on issues related to the application process for seeking approval for marketed unapproved drugs. This will be a 1-day workshop involving FDA staff and representatives from businesses currently marketing unapproved drugs. The purpose of the workshop is to provide clarification and direction to businesses on how to seek approval to legally market drugs through the new drug application (NDA) and abbreviated new drug application (ANDA) processes and how to legally market drugs through compliance with the over-the-counter (OTC) monographs.

 

       
Location: TBA Related News Links: Not Available
Time: 8:30AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsElectronic Submission of Regulatory Information

Meeting Date: 12/18/06-12/18/06

Meeting Details:

Electronic Submission of Regulatory Information, and Creating an Electronic Platform for Enhanced Information Management - The Food and Drug Administration (FDA) is announcing a public hearing to solicit general views and information from interested persons on issues concerning the electronic submission of product information to the agency. In particular, FDA is seeking these views and information from interested persons on the feasibility and effect of an all-electronic submission environment, as well as issues related to an electronic regulatory information exchange platform.

 

       
Location: TBA Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMedical Devices Dispute Resolution Panel

Meeting Date: 12/15/06-12/15/06

Meeting Details:

The committee will discuss, make recommendations, and vote regarding a scientific dispute between the agency and Acorn Corporation related to the approvability of a premarket approval application for the CorCap Cardiac Support Device for patients with dilated cardiomyopathy.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsJoint Anti-Infective Drugs & DSRM AdComm

Meeting Date: 12/14/06-12/15/06

Meeting Details:

On both days, the committee will discuss the overall benefit to risk considerations for the approved product KETEK (telithromycin), new drug application (NDA) 21-144, with the current indications of: Acute bacterial exacerbations of chronic bronchitis, acute bacterial sinusitis, and community acquired pneumonia, manufactured by Sanofi-Aventis.

 

       
Location: Crowne Plaza/Silver Spring Related News Links: Not Available
Time: 8:00AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPublic Workshop: National Drug Code (NDC)

Meeting Date: 12/11/06-12/11/06

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public meeting to discuss the proposed changes to the National Drug Code (NDC) system contained in the agency's proposed rule governing drug establishment registration and drug listing. The proposed rule appeared in the Federal Register of August 29, 2006 (71 FR 51276).

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsClinical Chemistry and Clinical Toxicology Devices Panel

Meeting Date: 12/6/06-12/6/06

Meeting Details:

The committee will hear an update on the status of recent devices brought before the committee. The committee will also hear a presentation regarding the FDA Critical Path Initiative. The committee will discuss general issues concerning lipoprotein (HDL and LDL) subfraction assays.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-4:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMCAC - Spinal Fusion

Meeting Date: 11/30/06-11/30/06

Meeting Details:

The incidence of low back pain at some time in a person’s lifetime in the U.S. population is reported to be as high as 90%. There are numerous causes of low back pain and men and women are equally afflicted. The degenerative changes that occur in the intervertebral disc in the spine are thought to be part of the normal process of aging and do not always lead to low back pain. Low back pain secondary to lumbar degenerative disc disease (DDD) can usually be successfully treated conservatively. However, when conservative treatment is not successful, surgical intervention becomes an option to relieve the pain associated with DDD. Since DDD is associated with the aging process, this is an affliction that is well represented in the Medicare population. CMS has a significant interest in discussing the evidence for surgical interventions for lumbar degenerative disc disease, with a specific focus on spinal fusion for low back pain associated with lumbar DDD in the Medicare population. The Medicare Coverage Advisory Committee (MCAC) will hear presentations and discuss evidence relative to indications for spinal fusion, clinical outcomes (including adverse events) and the persistence of outcomes over time, outcome measurement tools, and outcomes related to different surgical spinal fusion procedures, as well as, the generalizability of this evidence to the Medicare population.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-4:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsNanotechnology

Meeting Date: 10/10/06-10/10/06

Meeting Details:

For more information about nanotechnology, please use the link to the National Nanotechnology Initiative web site. This site also contains links to other federal agencies involved in nanotechnology http://www.nano.gov.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsFORUM/FDA Public CCR5

Meeting Date: 5/31/06-5/31/06

Meeting Details:

The Forum for Collaborative HIV Research and the FDA's Division of Antiviral Products are preparing to convene an open public meeting in early 2006. The purpose of this meeting is to discuss issues regarding the development of CCR5 co-receptor antagonists for the treatment of HIV infection, specifically mechanisms for long-term follow-up of patients enrolled in CCR5 antagonist clinical trials, potential consequences of tropism changes, and characterization of resistance to these investigational agents.

 

       
Location: Forum for Collaborative HIV Research Meeting Room Related News Links: Not Available
Time: 8:30AM-4:15PM    
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Meeting OptionsMeeting OptionsMeeting OptionsICH Public Meeting - (International Conference on Harmonization)

Meeting Date: 5/8/06-5/8/06

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public meeting entitled ``Preparation for ICH meetings in Yokohama, Japan'' to provide information and receive comments on the International Conference on Harmonization (ICH) as well as the upcoming meetings in Yokohama, Japan. The topics to be discussed are the topics for discussion at the forthcoming ICH Steering Committee Meeting. The purpose of the meeting is to solicit public input prior to the next Steering Committee and Expert Working Groups meetings in Yokohama, Japan on June 5 through 8, 2006, at which discussion of the topics underway and the future of ICH will continue.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 9:30AM-12:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsFDA/ASCO - Ovarian Cancer Public Workshop

Meeting Date: 4/26/06-4/26/06

Meeting Details:

FDA and the American Society of Clinical Oncology (ASCO), with co-sponsorship by the American Association for Cancer Research (AACR), April 26, 2006, 8:00 to 5:00 pm,

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 7:30AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsCellular, Tissue, and Gene Therapies AdComm

Meeting Date: 2/9/06-2/10/06

Meeting Details:

On February 9, 2006, in open session, the committee will conduct a scientific discussion of potency measurements for cellular and gene transfer products. On February 10, in open session, the committee will (1) Discuss the National Toxicology Program on Retroviral Mutagenesis and (2) receive a brief update on the recent review of the research program of the Office of Cellular, Tissue and Gene Therapies, FDA.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsFDA Counterfeit Drug Task Force Public Workshop

Meeting Date: 2/8/06-2/9/06

Meeting Details:

The purpose of the meeting is as follows: To identify incentives for widespread adoption of radio-frequency identification (RFID), as well as obstacles to the adoption of RFID across the U.S. drug supply chain and possible solutions to those obstacles; to solicit comment on the implementation of the pedigree requirements of the Prescription Drug Marketing Act (PDMA) and the use of an electronic pedigree (e-pedigree); and to learn the state of technology development related to electronic track and trace and e-pedigree technology solutions.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsClinical Trial End Points in Primary Brain Tumors

Meeting Date: 1/20/06-1/20/06

Meeting Details:

The Food and Drug Administration (FDA) is holding a public workshop on end points for primary brain tumors. Issues identified in the workshop will be further discussed before the Oncologic Drugs Advisory Committee (ODAC) and thereafter will be detailed in FDA Guidance Documents.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsFDA Communication of Drug Safety Information

Meeting Date: 12/7/05-12/8/05

Meeting Details:

The Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA) is announcing a public hearing on the Center's current risk communication strategies for human drugs. The public hearing announced in this notice is part of the agency's ongoing effort to improve CDER's risk communication. The purpose of the public hearing is to obtain public input on CDER's current risk communication tools, identify stakeholders for collaboration and implementation of additional tools, and obtain greater understanding of the strengths and weaknesses of CDER's existing risk communication.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMedicare Coverage Advisory Committee

Meeting Date: 11/29/05-11/29/05

Meeting Details:

Age-related macular degeneration (AMD) is the leading cause of legal blindness in Americans over the age of 65. The cause of AMD it is thought to be related to multiple factors, and there is no cure for the disease. There are two basic types of AMD: dry and wet. Dry AMD is the most common type, accounting for 90% of all cases. Wet AMD accounts for 10% of cases and poses a higher risk of severe vision loss. There is no definitive treatment for dry AMD. For patients with wet AMD, several treatments are available.

 

       
Location: Meeting Room Related News Links: Not Available
Time: 8:00AM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPrescription Drug User Fee Act (PDUFA) Public Meeting

Meeting Date: 11/14/05-11/14/05

Meeting Details:

The Food and Drug Administration (FDA) is holding a public meeting entitled "Prescription Drug User Fee Act (PDUFA): Public Meeting." We are convening the public meeting to hear stakeholder views as we prepare to work on amended authorizing legislation for PDUFA. The authority for PDUFA expires in September, 2007, and without further legislation, FDA would no longer be able to collect user fees for the prescription drug program. Resources critical to running the program would become unavailable to FDA. We are interested in hearing about people's experiences with and perceptions of PDUFA to date and what aspects of PDUFA should be changed or retained. In general, the meeting format will include presentations by FDA and a series of panels representing different stakeholder interest groups (such as patient advocates, consumer protection, industry, health professionals, and academic researchers)--see Agenda. We will also provide an opportunity for individuals to make comments at the meeting, and for organizations and individuals to submit written comments to the docket after the meeting.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsConsumer-Directed Promotion of Regulated Medical Products

Meeting Date: 11/1/05-11/2/05

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public hearing on direct-to-consumer (DTC) promotion of regulated medical products, including prescription drugs for humans and animals, vaccines, blood products, and medical devices. FDA is particularly interested in hearing the views of individuals and groups most affected by DTC promotion, including consumers, patients, caregivers, health professionals (physicians, physicians' assistants, dentists, nurses, pharmacists, veterinarians, and veterinarian technicians) managed care organizations, and insurers, as well as the regulated industry. FDA is seeking input on a number of specific questions, but is interested in any other pertinent information participants in the hearing would like to share.

 

       
Location: FDA Meeting Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsAcute Leukemia Endpoints

Meeting Date: 6/24/05-6/24/05

Meeting Details:

FDA Workshop on Clinical Trial Endpoints in Acute Leukemia: The U.S. Food and Drug Administration (FDA) is holding a public workshop on clinical endpoints in acute leukemia. The workshop will discuss clinical trial endpoints that have not been generally accepted but have potential utility for the measurement of clinical benefit or the prediction of clinical benefit with reasonable likelihood for the following disease entities: Pediatric Acute Lymphocytic Leukemia Adult Acute Lymphocytic Leukemia Pediatric Acute Myeloid Leukemia Adult Acute Myeloid Leukemia Acute Leukemia in the Elderly Issues identified in the workshops will be further discussed before the Oncologic Drugs Advisory Committee (ODAC) and thereafter will be detailed in FDA Guidance Documents.

 

       
Location: ASH / FDA Meeting Room Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsBiological Products for Treatment of Rare Plasma Protein

Meeting Date: 6/13/05-6/14/05

Meeting Details:

The Food and Drug Administration (FDA) Office of Public Health and Science in the Department of Health and Human Services, are announcing a public workshop entitled ``Biological Products for Treatment of Rare Plasma Protein Disorders.'' The purpose of the workshop is to discuss the scientific and regulatory challenges encountered during the development of biological products used to treat rare plasma protein disorders. The workshop also will include a discussion about options that could be used to facilitate future product development.

 

       
Location: NIH Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsLevothyroxine Sodium Therapeutic Equivalence

Meeting Date: 5/23/05-5/23/05

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public meeting on the therapeutic equivalence of levothyroxine sodium drug products. This meeting is being held in co-sponsorship with three medical societies: The American Thyroid Association (ATA), the Endocrine Society, and the American Association of Clinical Endocrinologists (AACE). The purpose of the public meeting is to discuss FDA's regulatory standards and methodological approaches for determining therapeutic equivalence between levothyroxine sodium drug products.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPreparation for International Conference on Harmonization (ICH)

Meeting Date: 4/20/05-4/20/05

Meeting Details:

FDA is announcing a public meeting entitled “Preparation for ICH meetings in Brussels, Belgium” to provide information and receive comments on the International Conference on Harmonization (ICH) as well as the upcoming meetings in Brussels, Belgium. The topics to be discussed are the topics for discussion at the forthcoming ICH Steering Committee Meeting and ICH Expert Working Groups. One of the topics for the upcoming ICH meeting is an Efficacy Brainstorming Session focusing on the review of the existing efficacy guidelines and their need for updating as well as potential new topics for consideration. The complete set of ICH Efficacy Guidelines may be found at http://www.ich.org or http://www.fda.gov/cder/guidance/guidance.htm#International Conference on Harmonisation.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 9:00AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsWorkshop: IRB INSTITUTIONAL REVIEW BOARDS

Meeting Date: 3/21/05-3/21/05

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public hearing to consider the process by which institutional review boards (IRBs) obtain and review information on adverse events that occur during the conduct of clinical investigations. FDA is increasingly aware of concerns within the IRB community that the process is burdensome, inefficient, and not as effective as it should be in providing IRBs the information they need to ensure that the rights and welfare of human subjects are protected during the course of a clinical study. The purpose of the hearing is to solicit information and views from interested persons on issues and concerns regarding the submission of adverse events to and their review by IRBs. FDA is seeking general information about the nature of the problem and possible solutions, responses to specific questions (see section III of this document), and any other pertinent information stakeholders would like to share.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsVeterinary Medicine Advisory Committee

Meeting Date: 1/31/05-1/31/05

Meeting Details:

At the January 31, 2005 meeting, VMAC will discuss and make recommendations regarding the voluntary recall of the veterinary drug product PROHEART 6 (sustained release moxidectin) and the Center's risk management strategy. Information concerning the issues of the voluntary recall of PROHEART 6 (NADA 141-189) manufactured by Fort Dodge Animal Health will be made publicly available to the VMAC members and the public in advance of the meeting and posted on the Center for Veterinary Medicine's Home Page . A limited number of paper copies of the background information will be available at the meeting.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsFDA, Merck and Vioxx: Putting Patient Safety First?

Meeting Date: 11/18/04-11/18/04

Meeting Details:

FDA, Merck and Vioxx: Putting Patient Safety First? November 18 , 2004, at 10:00 a.m. Member Statements: Charles Grassley, IA Max Baucus, MT Witness Statements: Panel I Dr. David J. Graham, MPH, Associate Director for Science, Office of Drug Safety, Center for Drug Evaluation and Research, U.S. Department of Health and Human Services, Food and Drug Administration, Washington, DC Panel II Dr. Gurkirpal Singh, Adjunct Clinical Professor of Medicine, Division of Gastroenterology and Hepatology, Department of Medicine, Stanford University School of Medicine, Stanford, CA Dr. Bruce M. Psaty, PhD, Professor, Medicine & Epidemiology, University of Washington, Cardiovascular Health Research Unit, Seattle, WA Panel III Dr. Sandra L. Kweder, Acting Director, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Department of Health and Human Services, Food and Drug Administration, Washington, DC Panel IV Mr. Raymond V. Gilmartin, Chairman, President & Chief Executive Officer, Merck & Co., Whitehouse Station, NJ

 

       
Location: Washington DC Related News Links: Not Available
Time: 10:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsRadioactive Drugs for Certain Research Uses

Meeting Date: 11/16/04-11/16/04

Meeting Details:

The Food and Drug Administration is holding a public meeting to discuss the use of radioactive drugs for basic research purposes under the Radioactive Drug Research Committee (RDRC) program described in the Code of Federal Regulations, Title 21, Part 361.

 

       
Location: FDA Rockville, MD Related News Links: Not Available
Time: 8:00AM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDietary Supplements - Premarket Notification for New Dietary

Meeting Date: 11/15/04-11/15/04

Meeting Details:

The Food and Drug Administration (FDA) is announcing a meeting and is soliciting comments on FDA's premarket notification program for new dietary ingredients (NDIs). FDA is soliciting comments from industry, consumers, and other interested members of the public concerning the content and format requirements for NDI notifications made under the Federal Food, Drug, and Cosmetic Act (the act). FDA is holding this meeting to give the public an opportunity to provide information and views on the topics outlined in this document. The agency intends to consider all comments received during the meeting and made to the docket in determining whether any future action is necessary or appropriate.

 

       
Location: FDA Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsFDA / HST Workshop Adaptive Designs for Clinical Trials

Meeting Date: 10/19/04-10/19/04

Meeting Details:

FDA and the Harvard-MIT Division of Health Sciences and Technology, are co-sponsoring a one-day workshop on October 19 entitled “Adaptive Clinical Trial Designs: Ready for Prime Time?” Speakers and panelists from academia, industry and FDA will present and discuss the potential advantages and downsides of recently proposed new designs that have been advocated as offering increased flexibility in drug development. Topics for this workshop include: Differences between new types of adaptive designs and more traditional designs that permit early stopping Potential advantages and disadvantages of new adaptive designs Regulatory perspective on use of adaptive designs The workshop is aimed at those involved in planning clinical trials programs, and those involved in designing, conducting and analyzing clinical trials. Speakers and Panelists Christy Chuang-Stein, Pfizer, Inc. Ralph B. D’Agostino, Boston University Susan S. Ellenberg, FDA Scott Emerson, University of Washington Thomas R. Fleming, University of Washington Howard J. Golub, Carestat, Inc. Hsien-Ming James Hung, FDA Cyrus R. Mehta, Cytel Software Corporation Jay P. Siegel, Centecor, Inc. Robert Temple, FDA Anastasios (Butch) Tsiatis, North Carolina State University

 

       
Location: FDA Related News Links: Not Available
Time: 8:30AM-5:15PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsFrom Concept to Consumer: Working with Stakeholders

Meeting Date: 10/7/04-10/7/04

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public workshop entitled “From Concept to Consumer: Center for Biologics Evaluation and Research (CBER) Working with Stakeholders on Scientific Opportunities for Facilitating Development of Vaccines, Blood and Blood Products, and Cellular, Tissue, and Gene Therapies.” The goal of the public workshop is to provide stakeholders a forum for the development of innovative scientific knowledge and tools to facilitate the development and availability of new biological products including vaccines, blood and blood products, and cellular, tissue, and gene therapies.

 

       
Location: The Gaithersburg Marriott Washingtonian Center Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsWorkshop: Follow-On Protein Products

Meeting Date: 9/14/04-9/15/04

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public workshop on scientific and technical considerations related to the development of follow-on protein pharmaceutical products. The agency is planning to develop draft guidance on this topic during the coming year. The purpose of this workshop is to obtain input from interested persons on the topics outlined in this document related to developing and approving follow-on protein pharmaceutical products. The agency will consider presentations made at the workshop and comments submitted to the docket before and after the workshop when developing the draft guidance.

 

       
Location: TBA Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsClinical Trial Endpoints in Prostate Cancer

Meeting Date: 6/21/04-6/22/04

Meeting Details:

The Food and Drug Administration (FDA) is holding a public workshop on endpoints for prostate cancer. Issues identified in the workshop will be further discussed before the Oncologic Drugs Advisory Committee (ODAC) and thereafter will be detailed in FDA Guidance Documents.

 

       
Location: Bethesda Marriott Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting Options(Part 11)Public Meeting on Electronic Record

Meeting Date: 6/11/04-6/11/04

Meeting Details:

Public Meeting on Electronic Record; Electronic Signatures (Part 11). What is Part 11? The Part 11 regulation went into effect on August 20, 1997, allowing FDA to accept electronic records and signatures in place of paper records and handwritten signatures.

 

       
Location: DC Related News Links: Not Available
Time: 8:00AM-4:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsStrategies for Developing Therapeutics That Directly Target Anthrax and Its Toxins

Meeting Date: 6/10/04-6/10/04

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Strategies for Developing Therapeutics That Directly Target Anthrax and Its Toxins.'' The goals of the public workshop are to provide a forum for sharing information and discussing strategies for safety and efficacy testing of therapeutics that target anthrax and its toxins in order to expedite the development of these FDA-regulated products; and to address the optimal studies for product characterization, proof of concept, and demonstration of safety and efficacy in postexposure prophylaxis and/or in the treatment of established disease. The workshop will cover therapies that involve monoclonal antibodies, other recombinant proteins, polyclonal immune globulin (human or animal) and small molecules that inhibit toxins. The workshop will not cover the use of vaccines and antimicrobial drugs targeting anthrax and its toxins.

 

       
Location: TBA Related News Links: Not Available
Time: 8:30AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsFDA/NIH Joint Symposium on Diabetes

Meeting Date: 5/13/04-5/14/04

Meeting Details:

Food and Drug Administration (FDA)/National Institutes of Health (NIH) Joint Symposium on Diabetes: Targeting Safe and Effective Prevention and Treatment. The purpose of the symposium is to define the current state of the prevention and management of diabetes and to identify and discuss therapeutic gaps and hurdles to safe and effective prevention and treatment of type 1 and type 2 diabetes mellitus. The symposium is intended to provide assistance to FDA, clinical and basic scientists, and the interested pharmaceutical industry in their efforts to reduce the burden of diabetes and improve the health of all people with diabetes. The symposium will provide a forum for discussion of diabetes-related topics, including the following: • Important disease outcomes that are or should be targeted in the development of drugs, devices, and cell-based therapies for type 1 and/or type 2 diabetes. • Issues surrounding the use of surrogate or intermediate measures of clinical effect in assessments of novel therapeutic approaches to prevention and treatment. • Clinical, scientific, and regulatory issues surrounding development of new medical technologies for the treatment of metabolic syndrome and for the prevention of type 2 diabetes. The symposium will include morning and afternoon sessions during which a discussion of diabetes and related issues associated with diabetes prevention and treatment will be presented. FDA and NIH are asking experts to provide presentations on specific issues, with discussion time following presentations between speakers and attendees.

 

       
Location: NIH Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDrug Safety and Risk Managment

Meeting Date: 5/5/04-5/5/04

Meeting Details:

From 8:00am - 3:00pm - The committee will discuss medication errors relating to the labeling and packaging of various drug products in low density polyeth plastic viles 3:00pm - 5:00pm - The committee will receive a progress report on the NDA 21-107 Lotronex (alosetron hydrochloride) produced by GSK with regards to the risk management program.

 

       
Location: Rockville Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsAntimicrobial Drug Development

Meeting Date: 4/15/04-4/16/04

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public workshop, cosponsored with the Infectious Diseases Society of America (IDSA) and the International Society of Anti-Infective Pharmacology (ISAP), regarding clinical trial design of antimicrobial agents. The public workshop is intended to provide information for and gain perspectives from advocacy groups, interested health care providers, academia, and industry organizations on various aspects of antimicrobial drug development, including a discussion of microbiological surrogate endpoints in clinical trials to evaluate treatments of infectious diseases and issues regarding dose selection in the drug development process for antimicrobials. The input from this public workshop will help to develop topics for further exploration.

 

       
Location: FDA Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPrescription Drug Importation

Meeting Date: 4/14/04-4/14/04

Meeting Details:

The FDA on behalf of the Department of Health and Human Services Task Force on Drug Importation, is announcing that it is establishing a docket to receive information and comments on certain issues related to the importation of prescription drugs. FDA is also announcing a public meeting to enable interested individuals, organization, and other stakeholders to present information to the Task Force for consideration in the study on importation mandated by the Medicare Prescription Drug, Improvement and Modernization Act of 2003. The Task Force is particularly interested in information related to whether and under what circumstances drug importation cold be conducted safely, and what circumstances drug importation could be conducted safely, and what its likely consequences would be for the health, medical costs, and development of new medicines for American patients.

 

       
Location: FDA - Bethesda Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDrug Safety and Risk Management Advisory Committee

Meeting Date: 12/4/03-12/4/03

Meeting Details:

The committee will discuss current screening methods to assess sound alike and look alike proprietary drug names, in order to reduce the incidence of medication errors resulting from look alike and sound alike names. This advisory committee meeting is in follow up to the FDA, Institute for Safe Medication Practices, and the Pharmaceutical Research and Manufacturers of America public meeting on the same subject, held on June 26, 2003.

 

       
Location: Holiday Inn GB Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsFACTOR VIII INHIBITORS

Meeting Date: 11/21/03-11/21/03

Meeting Details:

The purpose of the public workshop is to provide a forum for addressing regulatory and scientific concerns about inhibitors to Factor VIII, one of the components of blood necessary for clotting, with regard to inhibitor antibodies in Factor VIII products.

 

       
Location: NIH Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsFDA Workshop on Clinical Trial Endpoints in Colorectal Cancer

Meeting Date: 11/12/03-11/12/03

Meeting Details:

The Food and Drug Administration is holding a public workshop on endpoints for colorectal cancer.

 

       
Location: Marriott DC Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsFood and Drug Administration Obesity Working Group

Meeting Date: 10/23/03-10/23/03

Meeting Details:

The Food and Drug Administration (FDA) is announcing the following public meeting: Public Meeting on Obesity. The topic to be discussed involves issues within FDA's jurisdiction related to obesity and nutrition. The purpose of this public meeting, which is being sponsored by FDA's Obesity Working Group, is to discuss FDA's role and responsibilities in addressing the major public health problem of obesity, to focus on issues related to promoting better consumer dietary and lifestyle choices that have the potential to significantly improve the health and well-being of Americans, and to obtain stakeholder views on how best to build a framework for messages to consumers about reducing obesity and achieving better nutrition.

 

       
Location: NIH Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsAnti-Counterfeit Drug Initiative

Meeting Date: 10/15/03-10/15/03

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public meeting on the agency's effort to combat counterfeit drugs. The purpose of the meeting is to enable interested individuals, organizations, and other stakeholders to present information on all aspects of the agency's initiative against counterfeit drugs. FDA is particularly interested in hearing about information related to technology, public education, regulatory and legislative issues, and industry and health professional issues. The agency is also inviting vendors of anti- counterfeit technologies relevant to the pharmaceutical industry to display their products for the educational benefit of FDA and attendees. The objective of the meeting is for FDA to gather information to assist FDA's counterfeit drug task force in finalizing its report, which will include recommendations on steps that FDA, other government agencies, and the private sector can take to minimize the risks to the public from counterfeit drugs entering the supply chain.

 

       
Location: Bethesda, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsDirect-To-Consumer Promotion

Meeting Date: 9/22/03-9/23/03

Meeting Details:

The Food and Drug Administration (FDA) will hold a public meeting regarding direct-to-consumer (DTC) promotion of prescription drugs. The purpose of the meeting is for FDA and other persons and organizations to present the results of research on the promotion of prescription drug products directly to consumers through print, broadcast, and other types of media. FDA is particularly interested in hearing about research that provides insight into the effect that direct-to-consumer promotion has on the public health. FDA is also interested in research on the groups most affected by direct-to-consumer promotion, including patients, caretakers, physicians, physicians' assistants, nurses, pharmacists, managed care organizations, and insurers.

 

       
Location: National Transportation Safety Board Boardroom Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsDrug Safety and Risk Management Advisory Committee

Meeting Date: 9/18/03-9/19/03

Meeting Details:

On September 18, the committee will discuss medication errors relating to the labeling and packaging of various drug products in low-density polyethylene(LDPE) plastic vials. On September 19, the committee will discuss current screening methods to assess sound-alike and look-alike proprietary drug names in order to reduce the incidents in medication errors resulting from look-alike and sound-alike names.

 

       
Location: Holiday Inn - SS Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMedical Devices Dispute Resolution Panel - Meeting Cancelled

Meeting Date: 8/20/03-8/20/03

Meeting Details:

The committee will discuss, make recommendations, and vote regarding a scientific dispute between the agency and CardioGenesis Corp., related to the approvability of a premarket approval application for the Axcis Percutaneous Myocardial Revascularization (PMR) for late stage medically refractory angina.

 

       
Location: Bethesda, MD Related News Links: Not Available
Time: 8:00AM-7:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsCurrent Status of Useful Written Prescription Drug Info for Consumers

Meeting Date: 7/31/03-7/31/03

Meeting Details:

FDA is announcing a public meeting to discuss the current status of the private sector’s efforts to provide useful written prescription drug information to consumers.

 

       
Location: NTSB Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPublic Workshop: SARS Diagnostics: Scientific and Regulatory Challenges

Meeting Date: 7/14/03-7/14/03

Meeting Details:

The purpose of this workshop is to serve as a public forum for the academic and clinical communities (national and international), industry, other government agencies and the FDA to consider resources and methods to evaluate SARs diagnostic tests. In addition, the workshop serves as an opportunity to provide mechanisms for public-private partnerships and sharing of both information and resources to facilitate evaluation and safe use of new diagnostic tests. The FDA hopes to use the information gathered from this workshop to consider preliminary alternatives and options for advancing the science of SARS diagnostic tests. FDA hopes to identify specimen sources or specimen alternatives to help in the study of SARS.

 

       
Location: Rockville, MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPublic Workshop: Innovative Systems for Delivery of Drugs and Biologics

Meeting Date: 7/8/03-7/8/03

Meeting Details:

The purpose of this workshop is to serve as a forum for the academic and clinical communities, industry, and the FDA to discuss the latest scientific and clinical developments for these products, as well as any regulatory concerns and challenges. The FDA hopes to facilitate the development of new technology by addressing and clarifying regulatory uncertainty and by increasing the predictability of product development.

 

       
Location: Marriott, Pooks Hill Related News Links: Not Available
Time: 8:00AM-5:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPUBLIC MEETING - Minimizing Medication Errors

Meeting Date: 6/26/03-6/26/03

Meeting Details:

FDA has determined that many of the medication errors reported to the agency result from medical products having proprietary names that look or sound like the names of other medical products. Reducing the potential for medication errors due to proprietary name confusion is part of FDA's ongoing medical product risk management effort.

 

       
Location: Renaissance Hotel 999 9th Street, NW Washington, DC 20001 202 962 4470 Related News Links: Not Available
Time: 8:00AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCDER/CBER Risk Management Workshop

Meeting Date: 4/9/03-4/11/03

Meeting Details:

The Food and Drug Administration is announcing a public workshop to discuss risk management activities for drug and biologic products (excluding blood products other than plasma derivatives). The purpose of the workshop is to present FDA's current thoughts on risk management activities and to solicit views from the public. FDA is issuing three concept papers for discussion on risk assessment, risk management, and pharmacovigilance, which can be accessed below.

 

       
Location: NTSB Related News Links: Not Available
Time: 8:00AM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMCAC

Meeting Date: 2/12/03-2/12/03

Meeting Details:

This notice announces a public meeting of the Medicare Coverage Advisory Committee (the Committee). The Committee provides advice and recommendations to us about clinical issues. Among other things, the Committee advises us on whether adequate evidence exists to determine whether specific medical items and services are reasonable and necessary under Medicare law. The Committee will discuss and make recommendations concerning the quality of the evidence and related issues for the use of implantable cardioverter defibrillators (ICDs). We received a request from Guidant Corporation to cover ICDs for patients with a prior myocardial infarction and a left ventricular ejection fraction of <=.30. We are taking the opportunity to review all indications for ICDs.

 

       
Location: BCC Related News Links: Not Available
Time: 8:00AM-3:45AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsFDA Regulation of Combination Products

Meeting Date: 11/25/02-11/25/02

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public hearing to discuss the assignment, premarket review, and postmarket regulation of combination products. Combination products (defined in more detail later in this document) are products containing a combination of drugs, devices, or biological products. These products often are novel and have significant potential to enhance the public health. The purpose of the hearing is to solicit information and views from interested persons on the issues and concerns relating to the assignment, premarket review, and postmarket regulation of combination products. FDA is proposing specific questions, and the agency is interested in responses to these questions and any other pertinent information stakeholders would like to share.

 

       
Location: Rockville, MD. Related News Links: Not Available
Time: 9:00AM-5:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsANTIMICROBIAL DRUG DEVELOPMENT

Meeting Date: 11/19/02-11/20/02

Meeting Details:

The public workshop is intended to provide information for and gain perspective from advocacy groups, interested health care providers, academia, and industry organizations on various aspects of antimicrobial drug development, including the selection of delta in noninferiority (equivalence) clinical trials, the need for newer antimicrobial agents for the treatment of resistant pathogens, and clinical trial design. The input from this public workshop will help in developing topics for further exploration

 

       
Location: FDA Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsThe Cardiotoxicity Expert Working Group of the Nonclinical Studies Subcommittee

Meeting Date: 11/5/02-11/5/02

Meeting Details:

The Cardiotoxicity Expert Working Group of the Nonclinical Studies Subcommittee (NCSS) of the Advisory Committee for Pharmaceutical Science will meet to discuss biomarkers of drug-induced cardiotoxicity. The focus of this meeting will be to finalize a draft document concerning the utility of troponins I and T as valid biomarkers of drug-induced cardiac toxicity. The meeting will be held on November 5, 2002, from 1:30 p.m. to 5:00 p.m. in Conference Room K, and on November 6 from 8:00 to noon in Conference Room B, Parklawn Conference Center, 5600 Fishers Lane, Rockville, MD.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsNIH Scientific Workshop: Menopausal Hormone Therapy

Meeting Date: 10/23/02-10/24/02

Meeting Details:

This is a public meeting that will bring together researchers, health care practitioners, knowledgeable groups and consumers to review the current available scientific information and ongoing clinical trials regarding menopausal combination hormone therapy (HT/HRT) in the United States. The meeting will provide information about what recent study results mean for women who are taking menopausal combination hormones and what alternatives are available for specific conditions.

 

       
Location: NIH Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsThe Cardiotoxicity Expert Working Group of the Nonclinical Studies Subcommittee

Meeting Date: 8/28/02-8/29/02

Meeting Details:

The Cardiotoxicity Expert Working Group (EWG) of the Nonclinical Studies Subcommittee (NCSS) of the Advisory Committee for Pharmaceutical Science will meet to discuss biomarkers of drug-induced cardiotoxicity. The focus of this meeting will be to discuss and finalize a draft document concerning the utility troponins I and T as valid biomarkers of drug-induced cardiac toxicity, to determine future data needs, and to develop a publication review strategy. The EWG will also discuss additional biomarker candidates, and the feasibility of establishing partnerships to pursue these issues. In addition, a major objective will be to develop a white paper for presentation to the NCSS.

 

       
Location: FDA Building Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsBar Code Label Requirements for Human Drug Products

Meeting Date: 7/26/02-7/26/02

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public meeting to solicit comments for the development of a regulation on bar code labeling for human drug products, including biologic products. The FDA will also explore issues surrounding bar codes on medical devices. The FDA are holding this meeting to support the initiative of the Secretary of Health and Human Services to reduce medication errors.

 

       
Location: Bethesda, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsDrug Safety and Risk Management Advisory Committee

Meeting Date: 7/17/02-7/17/02

Meeting Details:

On July 17th, the FDA's Drug Safety and Risk Management Advisory Committee will discuss the ways to improve usefulness of Consumer Medical Information (CMI). The committee will consider (1) the potential causes of insufficiencies in CMI including current practices of the parties involved in developing and processing CMI in pharmacy practices that may affect the distributing incontent of CMI; (2) the potential intervention to address causes CMI insufficiencies in the current system and scientific method to assess and monitor whether communication of key information to patients is occuring.

 

       
Location: Holiday Inn, Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPublic Health Action Plan To Combat Antimicrobial Resistance

Meeting Date: 6/26/02-6/26/02

Meeting Details:

To present the first annual report of progress by Federal agencies in accomplishing activities outlined in A Public Health Action Plan to Combat Antimicrobial Resistance (Part I: Domestic Issues) and solicit comments from the public regarding the annual report. The Action Plan serves as a blueprint for activities of Federal agencies to address antimicrobial resistance. The focus of the plan is on domestic issues.

 

       
Location: Bethesda, MD Related News Links: Not Available
Time: 10:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsCombination Products Containing Live Cellular Components

Meeting Date: 6/24/02-6/24/02

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public hearing to discuss the jurisdictional classification, assignment, and premarket review of certain products that consist of living human cells in combination with a device matrix. The hearing will focus on products that are intended for wound healing (e.g., wound repair or skin regeneration, replacement, or reconstruction), although the information obtained may also be pertinent to questions concerning other combination products containing live cells. Combination products that include human cell or tissue components have significant potential to enhance the public health. The purpose of the hearing is to solicit information and views from interested persons, including scientists, clinical investigators, professional groups, trade groups, commercial enterprises, and consumers, on the issues and concerns relating to the premarket review and regulation of these combination products. To assist in the development of a consistent policy on jurisdiction for these products, FDA is interested in responses to specific questions and any other pertinent information stakeholders would like to share.

 

       
Location: Rockville, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsRisk Management of Prescription Drugs

Meeting Date: 5/22/02-5/22/02

Meeting Details:

The Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA) is announcing a public hearing on the agency's approach to risk management of prescription drugs. In May 1999, FDA published ``Managing the Risks From Medical Product Use,'' which laid a framework for the agency's efforts to reduce the risks involved with medical product use. The public hearing announced in this notice is part of the agency's ongoing efforts to improve CDER's risk communication and to develop new and effective risk management tools. The purpose of the hearing is to obtain public input on improving risk management of prescription drugs; identify stakeholders for further collaboration on development and implementation of risk management tools; obtain greater understanding of the strengths and weaknesses of existing risk management tools, which should help guide improvements or creation of new tools; and obtain input on strategies to assess the effectiveness of tools used for risk management of prescription drugs.

 

       
Location: National Transportation Safety Board Boardroom Washington, DC Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsScience Board to the FDA Advisory Committee

Meeting Date: 4/9/02-4/9/02

Meeting Details:

The board will hear and discuss emerging issues in antimicrobial resistance, process analytical technologies, and biomaterials innovation; and discuss the external science review for FDA's Office of Regulatory Affairs.

 

       
Location: TBA Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsPREPARATION FOR ICH MEETINGS IN BRUSSELS

Meeting Date: 1/17/02-1/17/02

Meeting Details:

The purpose of the public meeting is to solicit public input prior to the next Steering Committee and Expert Working Group meetings in Brussels, Belgium, February 4 through 7, at which discussion of the implementation of the CTD and the future of ICH will continue.

 

       
Location: FDA Advisory Conference Room Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting Options(DMC)New FDA Guidance on Clinical Trial Data Monitoring Committees

Meeting Date: 11/27/01-11/27/01

Meeting Details:

The purpose of the meeting is to present the Draft Guidance Document and solicit public comment. The document addresses scientific, ethical and practical issues related to the establishment and operation of data monitoring committees (DMCs) for clinical trials. Presentations at the meeting will cover the motivation for this guidance document, background on use of DMCs in clinical trials, determining the need for a DMC, establishment and operation of DMCs, the “independent” DMC, and the role of the DMC in meeting regulatory requirements. These formal presentations will be followed by panel discussions, and open public discussion. Input from the public is sought in finalizing the draft guidance.

 

       
Location: Hyatt Bethesda Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsElectronic Interchange Standard for Digital ECG and Similar Data

Meeting Date: 11/19/01-11/19/01

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public meeting to collect information regarding the content and format of electrocardiographic (ECG) data to be submitted to the agency in support of applications. The agency is interested in obtaining ECG waveform data in digital format from the full spectrum of ECG devices (i.e., standard 12-lead ECGs, Holter monitors, transtelephonic monitors, and implanted devices) along with annotations for events (e.g., standard ECG interval measurements, arrhythmic events).

 

       
Location: Rockville, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsTransportation Safety and Potentially Sedating or Impairing

Meeting Date: 11/14/01-11/15/01

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public meeting to gather data on the potential public health consequences related to sedating or impairing medications. This meeting will be jointly sponsored with the National Transportation Safety Board (NTSB). The meeting will be held to determine what data are available to define the role of sedating or impairing medications in accidents and related injuries, how the potential for medications to cause impairment might be best assessed, and how this risk would be most effectively communicated to the public.

 

       
Location: TBA Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsThe Cardiotoxicity Expert Working Group

Meeting Date: 10/12/01-10/12/01

Meeting Details:

The Cardiotoxicity Expert Working Group: will meet to discuss strategies to identify promising areas of nonclinical scientific research to develop biomarkers and/or other evolving molecular technologies to identify or predict drug-induced cardiac tissue injury on October 12, 2001, from 8:00 a.m. to 2:00 p.m. in the Parklawn building in the Potomac room.

 

       
Location: Rockville, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsPreparation for ICH Meetings in Brussels

Meeting Date: 10/5/01-10/5/01

Meeting Details:

Preparation for ICH Meetings in Brussels, Belgium, Including Progress on Implementing of the Common Technical Documents The purpose of the meeting is to solicit public input prior to the next Steering Committee and Expert Working Group meetings in Brussels, Belgium, October 22 to 25, at which discussion of the Common Technical Document and other topics related to the upcoming meeting in Brussels, Belgium will take place.

 

       
Location: Rockville Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsMedical Devices Dispute Resolution Panel

Meeting Date: 9/6/01-9/6/01

Meeting Details:

The committee will discuss, make recommendations, and vote regarding a scientific dispute between the agency and Lifecore Biomedical, Inc. related to the approvability of a premarket approval application for Intergel, an adhesion prevention solution.

 

       
Location: Rockville, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsPreparation for ICH Meetings in Tokyo, Japan

Meeting Date: 5/8/01-5/8/01

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public meeting entitled ``Preparation for ICH Meetings in Tokyo, Japan, Including Progress on the Common Technical Document and Possibilities for New Topics,'' to solicit information and receive comments on the future of the International Conference on Harmonisation (ICH) as well as the upcoming meetings in Tokyo, Japan. The topic to be discussed is the Common Technical Document (CTD) and possibilities for new topics. The purpose of the meeting is to solicit public input prior to the next Steering Committee and Expert Working Group meetings in Tokyo, Japan, May 21 to 24, 2001, at which discussion of the CTD and possible new topics will be continued.

 

       
Location: Rockville, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsELECTRONIC INVESTIGATIONAL NEW DRUG

Meeting Date: 1/26/01-1/26/01

Meeting Details:

The public meeting is to discuss the possibility of using XML to create a cumulative table of contents for IND's intended to be submitted electronically to CBER or CDER. The agency is hoping to gain public input at the meeting on the use of XML to create a cumulative table of contents.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsClinical Pharmacology during Pregnancy: Addressing clinical needs through science

Meeting Date: 12/4/00-12/5/00

Meeting Details:

The Food and Drug Administration (FDA) announces a FDA/National Institute for Child Health and Human Development (NICHD) co-sponsored conference "Clinical Pharmacology during Pregnancy: addressing clinical needs through science". The focus of the meeting will be drug therapeutics during the second and third trimester of pregnancy. The goals of the conference are: ----->To summarize the state of knowledge regarding clinical pharmacology in pregnancy ----->To raise awareness among clinician researchers and leaders about the need for clinical research and collaboration in this area ----->To garner support for such research from health advocacy groups and others

 

       
Location: Washington, D.C. Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsFDA Public Meeting

Meeting Date: 10/27/97-10/27/97

Meeting Details:

The Food and Drug Administration (FDA) is proposing new regulations requiring pediatric studies of certain new drug and biological products.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsReview of the Adverse Event Reporting System for Postmarketing Surveillance

Meeting Date: 3/17/97-3/17/97

Meeting Details:

The primary purpose of FDA's postmarketing surveillance program is to identify potentially serious drug safety problems, focusing especially on newly marketed drugs. Although premarket testing discloses a general safety profile of a new drug's comparatively common adverse effects, the larger and more diverse patient populations exposed to the marketed drug provides, for the first time, the opportunity to collect information on rare, latent, and long-term effects. Reports are obtained from a variety of sources, including patients, treating physicians, foreign regulatory agencies, and clinical investigators. Over 75 percent of the ADR reports that FDA receives are routed from health care practitioners through pharmaceutical companies. The remainder of the reports come directly to FDA through the agency's MedWatch program. FDA's computerized spontaneous reporting system (SRS) contains 1.4 million ADR reports for human drugs and therapeutic biologics. FDA plans to replace SRS with AERS by September 1997. All SRS historical data will be migrated to AERS. AERS will enable FDA to receive reports from pharmaceutical companies by electronic submission, transmitted data base to data base through standardized pathways. The technical specifications of the AERS computerized system will be described at the public meeting and made available to participants, especially as they relate to the electronic submission of expedited and periodic ADR reports. FDA has participated in the development of several guidelines by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) that relate to the submission of ADR reports under the AERS system: ``Clinical Safety Data Management: Definitions and Standards for Expedited Reporting'' (E2A); ``Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports'' (E2B); and ``Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (E2C). In addition, two other guidelines are currently under development by ICH: ``Medical Terminology (MEDDRA)'' (M1) and ``Electronic Standards for the Transfer of Regulatory Information (ESTRI)'' (M2). At the public meeting, FDA will explain how it intends to incorporate these recommended standards into the requirements for the electronic submission of ADR reports under AERS. The meeting will include a general discussion of CDER's plans to propose revisions to its postmarketing ADR reporting regulations. The goals of this rulemaking are to implement the recommendations in the ICH guidelines and to enhance the quality of ADR reports received by the agency. The agency hopes to familiarize the pharmaceutical industry with the procedures for the electronic submission of ADR reports under AERS so that they are prepared to comply with any revised regulations that may issue as a result of the rulemaking initiative.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsADVERTISING AND PROMOTION OF MEDICAL PRODUCTS

Meeting Date: 10/16/96-10/17/96

Meeting Details:

The FDA discussed advertising and promotion of medical products over the internet.

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsFDA Public Meeting

Meeting Date: 9/13/96-9/13/96

Meeting Details:

Validating packaging integrity of synthetic absorbable sutures: accelerated aging in vivo and in vitro testing.

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsPublic Meeting

Meeting Date: 3/8/96-3/8/96

Meeting Details:

Public Law 103-417, Section 12, authorized the establishment of a Commission on Dietary Supplement Labels whose seven members have been appointed by the President. The appointments to the Commission by the President and the establishment of the Commission by the Secretary of Health and Human Services reflect the commitment of the President and the Secretary to the development of a sound and consistent regulatory policy on labeling of dietary supplements. The Commission is charged with conducting a study and providing recommendations for regulation of label claims and statements for dietary supplements, including the use of supplemental literature in connection with their sale and, in addition, procedures for evaluation of label claims. The Commission is expected to evaluate how best to provide truthful, scientifically valid, and non-misleading information to consumers in order that they may make informed health care choices for themselves and their families. The Commission's study report may include recommendations on legislation, if appropriate and necessary.

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsDietary Supplement Labels

Meeting Date: 2/16/96-2/16/96

Meeting Details:

The Commission was charged with conducting a study on, and providing recommendations for regulating label claims and statements for dietary supplements, including the use of literature in connection with the sale of dietary supplements and procedures for evaluating such claims.

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsFDA Public Meeting

Meeting Date: 10/30/95-10/30/95

Meeting Details:

The committee discussed prescription drug labeling for healthcare professionals.

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsFDA Public Meeting

Meeting Date: 10/19/95-10/20/95

Meeting Details:

Pharmaceutical Marketing and Information Exchange in Managed Care Environments

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsFDA Public Meeting

Meeting Date: 10/18/95-10/18/95

Meeting Details:

Direct-to-Consumer Promotion of Prescription Drugs

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsFinancial Disclosure by Clinical Investigators

Meeting Date: 7/20/95-7/20/95

Meeting Details:

Financial Disclosure by Clinical Investigators

 

       
Location: N/A Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm

Meeting Date: 10/30/14-10/30/14

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Meeting Details:

The committee will discuss new drug application (NDA) 206316, edoxaban tablets, submitted by Daiichi Sankyo, Inc., for the prevention of stroke and systemic embolism (blood clots other than in the head) in patients with nonvalvular atrial fibrillation (A Fib; abnormally rapid and chaotic contractions of the atria, the upper chambers of the heart).

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs AdComm

Meeting Date: 11/6/14-11/6/14

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Meeting Details:

During the morning session, the committee will discuss New Drug Application (NDA) 205353, panobinostat capsules, application submitted by Novartis Pharmaceuticals Corporation. The proposed indication (use) for this product is in combination with bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least 1 prior therapy. During the afternoon session, the committee will discuss NDA 206317, ferric pyrophosphate solution, for administration via hemodialysis dialysate, application submitted by Rockwell Medical, Inc. The proposed indications (uses) for this product are for the treatment of iron loss or iron deficiency to maintain hemoglobin in adult patients with hemodialysis-dependent stage 5 chronic kidney disease (CKD 5HD) and to reduce the prescribed dose of erythropoiesis stimulating agent (ESA) required to maintain desired hemoglobin levels.

 

       
Location: The Great Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOphthalmic Devices Panel

Meeting Date: 11/14/14-11/14/14

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Meeting Details:

On November 14, 2014, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the AcrySof® IQ ReSTOR® Multifocal Toric Posterior Chamber Intraocular Lens submitted by applicant Alcon Laboratories, Inc. This intraocular lens combines the optical properties of a +3 diopter multifocal intraocular lens with the optical properties of a toric intraocular lens. The proposed indication for use is: The AcrySof® IQ ReSTOR® Multifocal Toric Posterior Chamber Intraocular Lens (IOL) are intended for primary implantation for the visual correction of aphakia and pre-existing astigmatism secondary to removal of a cataractous lens in adult patients with and without presbyopia, who desire near, intermediate and distance vision, reduction of residual refractive cylinder, and increased spectacle independence. The lens is intended to be placed in the capsular bag.

 

       
Location: Hilton/Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Analgesic Drug Products AdComm

Meeting Date: 11/24/14-11/25/14

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Meeting Details:

The committee will discuss the risk of serious neurologic adverse reactions associated with epidural steroid injections (ESI) administered to reduce inflammation for pain management. The committee will also consider the efficacy of ESI and the overall risk benefit balance of injecting steroids in the epidural space to treat pain. These considerations will assist the Agency in our discussions of possible regulatory options, including but not limited to changes to the product labeling.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drug AdComm

Meeting Date: 12/4/14-12/4/14

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Meeting Details:

The committee will discuss issues related to clinical development programs and clinical trial designs for antibacterial products for the treatment of patients with serious bacterial infections for which there are limited or no therapeutic options.

 

       
Location: The Marriott Inn and Conference Center Related News Links: Not Available
Time: 8:30AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel

Meeting Date: 12/12/14-12/12/14

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Meeting Details:

On December 12, 2014, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application for the Superion InterSpinous Spacer device sponsored by Vertiflex Incorporated. The proposed Indication for Use for the Superion InterSpinous Spacer device, as stated in the PMA, is as follows: the Superion InterSpinous Spacer (the Superion ISS) is intended to treat skeletally mature patients suffering from pain, numbness, and/or cramping in the legs (neurogenic intermittent claudication) secondary to a diagnosis of moderate lumbar spinal stenosis, with or without Grade 1 spondylolisthesis, confirmed by X-ray, MRI and/or CT evidence of thickened ligamentum flavum, narrowed lateral recess, and/or central canal or foraminal narrowing. The Superion ISS is indicated for those patients with impaired physical function who experience relief in flexion from symptoms of leg/buttock/groin pain, numbness, and/or cramping, with or without back pain. The Superion ISS may be implanted at one or two adjacent lumbar (L) levels in patients in whom treatment is indicated at no more than two levels, from L1 to L5.

 

       
Location: Holiday Inn-College Park Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

Meeting Date: 10/21/14-10/21/14

Meeting Details:

The committee will discuss supplemental new drug application (sNDA) 203188, ivacaftor oral tablets, submitted by Vertex Pharmaceuticals Inc., for the treatment of cystic fibrosis in patients with an R117H mutation in the cystic fibrosis transmembrane conductance regulator gene.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs AdComm

Meeting Date: 10/20/14-10/20/14

Meeting Details:

The committee will discuss biologics license application (BLA) 125504, secukinumab, a human monoclonal antibody, submitted by Novartis, proposed for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the Psychopharmacologic Drugs & DSRM

Meeting Date: 10/16/14-10/16/14

Meeting Details:

The committees will discuss the risk of serious neuropsychiatric adverse events with CHANTIX (varenicline tartrate) tablets, NDA 21928, Pfizer, Inc., and discuss options for addressing this risk.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 10/8/14-10/9/14

Meeting Details:

On October 8, the committee will discuss, make recommendations and vote on information related to the premarket approval application regarding the Boston Scientific Corporation’s WATCHMAN Left Atrial Appendage (LAA) Closure Technology. FDA is seeking committee review and recommendations regarding new clinical data and associated additional adverse events including stroke that have become available since the previous advisory committee meeting on the WATCHMAN device, which was held December 11, 2013. The WATCHMAN LAA Closure Technology is a percutaneously delivered permanent cardiac implant placed in the left atrial appendage. This device is indicated to prevent thromboembolism (TE) from the left atrial appendage. It may be considered for use in patients with non-valvular atrial fibrillation who are eligible for warfarin therapy to reduce the risk of stroke and systemic embolism based on CHADS2 (congestive heart failure, hypertension, age >75 years, diabetes, and prior stroke or transient ischemic attack (TIA)) or CHA2DS2-VASc (congestive heart failure, hypertension, age >75 years, diabetes mellitus, stroke/TIA/TE, vascular disease, age 65-74, and sex category) scores. On October 9, the committee will discuss and make recommendations regarding the classification of more-than-minimally manipulated allograft heart valves (MMM Allograft HVs). A MMM Allograft HV is a human valve or valved conduit that has been aseptically recovered from qualified donors, dissected free from the human heart, and then subjected to a manufacturing process(es) that alters the original relevant characteristics of the tissue (21 CFR 1271.3(f), 21 CFR 1271.10(a)(1), and 21 CFR 1271.20). The valve is then stored until needed by a recipient. An example of such a manufacturing process is one that intentionally removes the cells and cellular debris with the goal of reducing in vivo antigenicity. MMM Allograft HVs are considered preamendment devices because they were found substantially equivalent to devices in commercial distribution prior to May 28, 1976, when the Medical Device Amendments became effective. MMM Allograft HVs are currently regulated under Product Code OHA, ‘‘Heart Valve, More than Minimally Manipulated Allograft,’’ as unclassified devices and reviewed under the premarket notification, 510(k), authority (21 CFR part 807). FDA is seeking committee input on the safety and effectiveness of MMM Allograft HVs and the regulatory classification for MMM Allograft HVs.

 

       
Location: Hilton Gaithersburg MD Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel

Meeting Date: 10/1/14-10/1/14

Meeting Details:

On October 1, 2014, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for the SONABLATE 450 device sponsored by SonaCare Medical, LLC. The proposed Indication for Use for the SONABLATE 450 device, as stated in the PMA, is as follows: The SONABLATE 450 (SONABLATE) is intended for use in the treatment of localized, clinically recurrent prostate cancer after failure of primary external beam radiation therapy.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsPediatric AdComm

Meeting Date: 9/23/14-9/23/14

Meeting Details:

The Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act for: AFINITOR DISPERZ (everolimus); Berlin Heart EXCOR® Pediatric Ventricular Assist Device; CONTEGRA® Pulmonary Valved Conduit; DYMISTA (azelastine hydrochloride; fluticasone propionate); Elana Surgical Kit; ENTERRA Therapy System; LEVAQUIN (levofloxacin); LEXIVA (fosamprenavir calcium); QNASL (beclomethasone diproprionate), Medtronic Melody® Transcatheter Pulmonary Valve; MENHIBRIX (Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine); SINGULAIR (montelukast sodium); TREANDA (bendamustine hydrochloride); VERAMYST (fluticasone furoate); VIREAD (tenofovirdisoproxil fumarate); and VOLUVEN (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection).

 

       
Location: Pooks Hill Related News Links: Not Available
Time: 8:00AM-5:30PM    
Materials:
   
       

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Past Meetings

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