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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsImmune Responses to Enzyme Replacement Therapies: Role of Immune Tolerance Induction

Meeting Date: 6/9/14-6/9/14

Meeting Details:

The Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research, in cosponsorship with the National Organization for Rare Disorders (NORD), is announcing a 1-day public workshop entitled ‘‘Immune Responses to Enzyme Replacement Therapies: Role of Immune Tolerance Induction.’’ Partners and stakeholders planning the workshop also include representatives from academia, industry, and patients. The purpose of this workshop is to provide a forum to discuss the role of immune tolerance induction in patients receiving replacement biological products.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsRisk Evaluation and Mitigation Strategy Assessments

Meeting Date: 6/7/12-6/7/12

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public workshop entitled “Risk Evaluation and Mitigation Strategy Assessments: Social Science Methodologies to Assess Goals Related to Knowledge.” The purpose of the public workshop is to initiate constructive dialogue and information-sharing among regulators, researchers, the pharmaceutical industry, health care organizations, health care providers, and others from the general public about survey methodologies and instruments that can be used to evaluate patients’ and health care providers’ knowledge about the risks of drugs marketed with an approved REMS. The input from this workshop will be used to develop guidance for industry describing best practices for conducting an assessment of a REMS goal regarding patient and/or health care provider knowledge about a drug’s risk(s). To assist in the workshop discussion and the ultimate development of the guidance, FDA is making available an issue paper that discusses our experience with knowledge assessments for REMS and contains specific questions we hope to receive input on.

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsASH/FDA Multiple Myeloma Clinical Endpoints Workshop

Meeting Date: 10/26/06-10/26/06

Meeting Details:

This important workshop on multiple myeloma will explore endpoints that represent clinical benefits other than overall survival in the following areas: Workshop Co-Chairs Kenneth C. Anderson, MD • Dana-Farber Cancer Institute Richard Pazdur, MD • Director, Office of Oncology Drug Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration This important workshop on multiple myeloma will explore endpoints that represent clinical benefits other than overall survival in the following areas: Monoclonal Gammopathy of Unclear Significance (MGUS) Subcommittee Chair: Robert A. Kyle, MD • Mayo Clinic, Rochester, MN Newly Diagnosed Subcommittee Chair: S. Vincent Rajkumar, MD • Mayo Clinic, Rochester, MN Relapsed Subcommittee Chair: Donna Weber, MD • M.D. Anderson Cancer Center, Houston, TX Refractory Subcommittee Chair: William S. Dalton, MD, PhD • H. Lee Moffitt Cancer Center, The University of South Florida, Tampa, FL Maintenance Subcommittee Chair: Jean-Luc Harousseau, MD • University Hospital Hôtel-Dieu, Nantes, France

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:30AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsOverview of the ECG Warehouse and Review Process

Meeting Date: 9/30/05-9/30/05

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public workshop entitled: Overview of the ECG Warehouse and Review Process. The purpose of the workshop is to communicate to industry the logistics of ECG waveform review as a part of the application review process. The ECG Warehouse, an annotated Electrocardiogram waveform data (aECG) storage and review system, is being incorporated into the FDA’s set of tools. This workshop will inform industry how to make aECG source data available to reviewers through the ECG Warehouse. This workshop will also overview the types of information the ECG Warehouse provides reviewers and will give examples of problematic aECGs already found. Traditionally, the Food and Drug Administration (FDA) has received only summary representations of electrocardiogram data for the analysis of safety and efficacy of products. The FDA is interested in improving the evaluation of specific drug-induced cardiac toxicity by evaluating ECG waveform data with detailed, sponsor-generated annotations from the full spectrum of ECG devices including 12-lead standard ECG, Holter monitors, and implanted devices. The FDA entered into a Cooperative Research and Development Agreement with Mortara Instrument, Inc. to develop a data warehouse application and viewing tool for aECG in the format specified in the Health Level Seven standard accredited by the American National Standards Institute. A web-based system supports communication with the sponsor for uploading, receipt, validation, transformation, and warehousing of aECG source data. The warehouse enables the FDA to evaluate aECG source data for evidence of cardiac toxicity and the viewing tool allows reviewers to selectively display waveforms and annotations. FDA is holding a public meeting to communicate the availability of the ECG Warehouse for FDA reviewers and the need for industry to upload aECGs into it. The agenda for this meeting, which will include an overview of the software capabilities and examples of problematic aECGs, will be available on the Internet at http://www.fda.gov/cder/regulatory/ersr/default.htm before the meeting.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 9:30AM-11:30AM    
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Meeting OptionsMeeting OptionsMeeting OptionsInternational Symposium on Combination Vaccines

Meeting Date: 2/2/00-2/4/00

Meeting Details:

The 3-day International Symposium on Combination Vaccines will explore the laboratory, clinical, and epidemiologic issues that are integral to the development and licensing of new combination vaccines that are both safe and effective. Increased complexity of the recommended childhood immunization schedule has heightened demand for additional combination vaccines that will convey immunity to more than one antigen. Many important benefits can be derived from the use of combination vaccines, including higher rates of immunization—particularly among less accessible populations—and reduced costs. However, a series of scientific and practical challenges will need to be addressed to expedite the widespread development of safe and effective combination vaccines.Among these challenges are (1) the potential for diminished immune response, (2) development, acceptance, and use of correlates of protection, (3) design and analysis of studies to evaluate safety (4) considerations for simultaneous administration, (5) manufacturing, product testing, and preclinical (animal) evaluation, and (6) challenges to use of combination vaccines.

 

       
Location: NIH Bethesda, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsFDA Workshop

Meeting Date: 12/18/96-12/18/96

Meeting Details:

The FDA review clinical safety data.

 

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

Meeting Date: 7/23/96-7/23/96

Meeting Details:

The FDA has outlined a policy for drug development for Juvenile Rheumatoid Arthritis which encourages sponsor licensing products for adult RA to simultaneously obtain dosing and safety data in polyarticular course JRA for inclusion in the dosing and pediatric use sections of the label.

 

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

Meeting Date: 4/19/96-4/19/96

Meeting Details:

FDA Guidance Concerning Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-derived Products FDA is issuing this guidance document as part of its on-going initiatives to provide manufacturers with increased flexibility to bring important and improved human biological products to market more efficiently and expeditiously. This document addresses the concept of product comparability and describes current FDA practice concerning product comparability of human biological products regulated by the Center for Biologics Evaluation and Research (CBER), including therapeutic biotechnology-derived products, regulated by CBER, and therapeutic biotechnology-derived products regulated by the Center for Drug Evaluation and Research (CDER).

 

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

Meeting Date: 3/27/96-3/27/96

Meeting Details:

The FDA developed and reviewed the guidelines to assist developers of drugs, biological products, and medical devices intended for the treatment of rheumatoid arthritis (RA). The FDA also discussed the types of label claims that can be considered for such products and provides guidance on the clinical development programs to support those claims.

 

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

Meeting Date: 2/14/96-2/15/96

Meeting Details:

The Food and Drug Administration (FDA) is announcing a public meeting to pass Public Law 104-180 mandating that the private sector be given the opportunity to meet distribution and quality goals for written patient prescription medicine information.

 

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

Meeting Date: 12/11/95-12/13/95

Meeting Details:

FDA regulates "Well-characterized" biologicals.

 

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

Meeting Date: 11/6/95-11/7/95

Meeting Details:

The committee will review the 1993 Gender Studies in Product Development Guideline and to consider the need to provide further clarification.

 

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

Meeting Date: 9/6/95-9/7/95

Meeting Details:

The subcommittee will hear summary presentations from discussions held during the public workshop on current issues in AIDS clinical trials to be held on September 6 and 7, 1995, (announced elsewhere in this issue of the Federal Register) and discuss recommendations on the scientific design of AIDS clinical trials.

 

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

Meeting Date: 3/23/95-3/23/95

Meeting Details:

The FDA discussed to improve cost-effectiveness of healthcare.

 

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

Meeting Date: 3/21/95-3/21/95

Meeting Details:

FDA has taken into consideration relevant issues, concerns, and questions raised at the public meetings held with professional associations, producers of PET drug products, and other interested parties.

 

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

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPediatric AdComm

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

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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    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel

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

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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    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

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

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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    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the Psychopharmacologic Drugs & DSRM

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

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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    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs AdComm

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

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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    
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Recent 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 OptionsEndocrinologic and Metabolic Drugs AdComm (NPS Pharma)

Meeting Date: 9/12/14-9/12/14

Meeting Details:

The committee will discuss biologics license application (BLA) 125511, proposed trade name NATPARA (established name: Recombinant Human Parathyroid Hormone (rDNA) or (rhPTH[1-84]), submitted by NPS Pharmaceuticals, Inc., for the proposed indication of replacement for endogenous parathyroid hormone (1-84) for the long-term treatment of hypoparathyroidism.

 

       
Location: Marriott Inn and Conference Center College Park, MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm (Novo Nordisk)

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

Meeting Details:

The committee will discuss the safety and efficacy of new drug application (NDA) 206321, liraglutide for injection, sponsored by Novo Nordisk, Inc. The proposed indication for liraglutide is as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kilograms per square meter (kg/m2) or greater, or with an initial BMI of 27 kg/m2 or greater in the presence of at least one weight-related comorbidity.

 

       
Location: Marriott Inn and Conference Center College Park, MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm

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

Meeting Details:

The committee will be asked to discuss the potential clinical utility of fixed-combination prescription drugs composed of an anti-hypertensive drug, aspirin, and a statin administered to reduce the risk of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke in patients with a history of cardiovascular disease. The committee will be asked to discuss the patient population that could benefit from such a product, whether that population would be likely to take such a drug long term, and how this could be assured. The committee will also be asked to consider the pros and cons of a treatment that would not be titrated and in a setting where monitoring might not be rigorous.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-4:30PM    
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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 OptionsCardiovascular and Renal Drugs AdComm (Forrest Labs)

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

Meeting Details:

The committee will discuss new drug application (NDA) 206302, nebivolol/valsartan fixed-dose combination tablets (5/80 milligrams (mg), 5/160 mg, 10/160 mg, 10/320 mg and 20/320 mg), submitted by Forrest Laboratories, Inc., for the proposed indication of the treatment of hypertension.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 12:00PM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsNonprescription Drugs AdComm

Meeting Date: 9/3/14-9/5/14

Meeting Details:

The committee will discuss the standards used to demonstrate that over-the-counter (OTC) topical antiseptics used in healthcare settings are generally recognized as safe and effective. The discussion will focus on antiseptic active ingredients marketed under the OTC Drug Review (also known as the OTC Drug Monograph) for the following healthcare antiseptic uses: healthcare personnel hand washes and rubs, surgical hand scrubs and rubs, and patient preoperative and preinjection skin preparations. On September 4-5, 2014, the committee will discuss the scope of safety testing that should be required for sunscreen active ingredients to be marketed in U.S. over-the-counter (OTC) sunscreen products. This discussion will take into consideration that sunscreens are typically used chronically in individuals over the age of 6 months to help prevent skin cancer and skin aging. The need for various types of safety data, including clinical data and nonclinical data, will be discussed.

 

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

Below is a listing of all committees. Select a committee to display all meetings available for that committee.

Live Meetings

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