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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsTransmissible Spongiform Encephalopathies AdComm

Meeting Date: 8/1/11-8/1/11

Meeting Details:

On August 1, 2011, in the morning, the committee will discuss donor deferral for time spent in Saudi Arabia to reduce the risk of variant Creutzfeldt-Jakob disease (vCJD) by blood and blood products and human cells, tissues and cellular and tissue-based products.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 9:00AM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsTransmissible Spongiform Encephalopathies AdComm

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

Meeting Details:

On October 28, 2010, the Committee will discuss: (1) FDA's risk assessment for potential exposure to the variant Creutzfeldt-Jakob disease (vCJD) agent in U.S.-licensed plasma-derived Factor VIII and (2) labeling of blood and blood components and plasma-derived products, including plasma-derived albumin and products containing plasma-derived albumin, to address the possible risk of transmission of vCJD. On October 29, 2010, the Committee will hear informational presentations related to FDA's geographic donor deferral policy to reduce the possible risk of transmission of CJD and vCJD by blood and blood products and human cells, and tissue and cellular and tissue based products. The Committee will also hear updates on the following topics: The development of devices to remove transmissible spongiform encephalopathy agents from blood components and chronic wasting disease.

 

       
Location: HOL GB Related News Links: Not Available
Time: 8:30AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsTransmissible Spongiform Encephalopathies AdComm

Meeting Date: 6/12/09-6/12/09

Meeting Details:

On June 12, 2009, the Committee will review and discuss a recent report from the UK Health Protection Agency attributing a case of variant Creutzfeldt-Jakob (vCJD) disease infection to treatment 11 years earlier with a ``vCJD-implicated'' plasma-derived coagulation factor VIII (pdFVIII) and whether this information or any other recent scientific information about the vCJD epidemic substantially alters FDA's risk assessment for U.S.-licensed preparations of pdFVIII products. In the afternoon the committee will hear informational presentations on animal models of vCJD, diagnostic test development for transmissible spongiform encephalopathies (TSEs) and bovine spongiform encephalopathy (BSE) surveillance and risk management.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsTransmissible Spongiform Encephalopathies AdComm

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

Meeting Details:

On December 15, 2006, the committee will discuss FDA's risk assessment for potential exposure to variant Creutzfeldt-Jakob disease in human plasma-derived antihemophilic factor (FVIII) products manufactured from U. S. plasma donors and related communication materials. In the afternoon, the committee will discuss levels of transmissible spongiform encephalopathy clearance in the manufacture of plasma-derived Factor VIII products.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-3:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsTransmissible Spongiform Encephalopathies AdComm

Meeting Date: 9/18/06-9/19/06

Meeting Details:

On September 18, 2006, the committee will hear updates on the following topics: United States and worldwide bovine spongiform encephalopathies (BSE); variant Creutzfeldt-Jakob disease (vCJD) epidemiology and transfusion-transmission; blood and plasma donor deferral for transfusion in France since 1980 guidance; FDA's current assessment and plans regarding the potential exposure to vCJD from an investigational product, FXI, that was manufactured from UK donor plasma; and a summary of World Heath Organization Consultation on distribution of infectivity in tissues of animals and humans with transmissible spongiform encephalopathies. The committee will then discuss experimental clearance of transmissible spongiform encephalopathy infectivity in plasma-derived Factor VIII products. In the afternoon, the committee will discuss FDA's risk assessment for potential exposure to vCJD from human plasma-derived antihemophilic factor (FVIII) products and potential responses. On September 19, 2006, the committee will discuss possible criteria for approval of donor screening tests for vCJD.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-4:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsTransmissible Spongiform Encephalopathies AdComm

Meeting Date: 10/31/05-10/31/05

Meeting Details:

On October 31, 2005 the Committee will hear updates on the following topics: Current status of bovine spongiform encephalopathy (BSE) in the United States, incidence and prevalence worldwide of variant Creutzfeldt-Jakob Disease (vCJD), and a summary of the FDA Device Panel discussion on September 27, 2005 on criteria for considering label claims of effective decontamination for surgical instruments exposed to transmissible spongiform encephalopathy (TSE) agents. The Committee will then discuss progress in development of a risk assessment model for vCJD in U.S.-licensed human plasma-derived Antihemophilic Factor (Factor VIII). The latter discussion will focus on selection of input parameters for the model. In the afternoon, the Committee will discuss labeling claims for TSE clearance studies for blood component filters.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsTransmissible Spongiform Encephalopathies Advisory Committee

Meeting Date: 2/8/05-2/8/05

Meeting Details:

The committee will discuss the following: (1) Risk assessments for potential exposure to the variant Creutzfeldt-Jakob disease (vCJD) agent in plasma products, (2) possible vCJD risk from investigational coagulation Factor XI manufactured in the 1990s from plasma of donors residing in the United Kingdom, and (3) potential deferral of blood and plasma donors for history of transfusion in France and other European countries.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsTransmissible Spongiform Encephalopathies Advisory Committee

Meeting Date: 10/14/04-10/14/04

Meeting Details:

On October 14, 2004, the Committee will hear updates on: USDA-licensed tests for the diagnosis of bovine spongiform encephalopathy (BSE) and other transmissible spongiform encephalopathies (TSE), review of the worldwide BSE situation, new FDA/CFSAN BSE-food safety rules, and labeling claims for TSE clearance studies for plasma derivative products. The Committee will then discuss and make recommendations regarding presumptive transfusion transmissions of variant Creutzfeldt Jakob Disease (vCJD) and current FDA-recommended safeguards.

 

       
Location: Hilton-Washington DC/Silver Spring Related News Links: Not Available
Time: 8:00AM-5:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsTransmissible Spongiform Encephalopathies Advisory Committee

Meeting Date: 2/12/04-2/13/04

Meeting Details:

On February 12, 2004, the Committee will hear an informational presentation on the presumptive transfusion-transmitted case of variant Creutzfeldt-Jakob Disease (vCJD) reported recently in the United Kingdom, and hear updates on related experimental studies in animals on transmission of TSE agents by blood, and relevant epidemiology of human TSE’s. In the afternoon, the Committee will receive an update on the case of bovine spongiform encephalopathy (BSE) recently recognized in the United States, and will have a general discussion about potential models of risk-based approaches to sourcing of bovine materials used to make medical products. On February 13, 2004, the Committee will have a preliminary discussion about FDA’s current recommendations on measures to minimize risk from TSE agents in various types of medical products.

 

       
Location: Holiday Inn Silver Spring, MD Related News Links: Not Available
Time: 8:00AM-5:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsT.S.E. Advisory Committee

Meeting Date: 7/17/03-7/18/03

Meeting Details:

On July 17, 2003, the committee will discuss the saftey of bovine bone gelitine and oral and topical drugs food and cosmetics. The committee will then discuss bovine spongiform encephalopathy in Canada and potential implecations for FDA regugulated products. In the afternoon the committee will hear presentations on TSE and decontaminations of medical equipment and facilities. On July 18, the committee will dicuss designing interpreting and validating studies to evaluate reprocess methods for removing TSE contamination from medical devices. In the afternoon the committee will discuss methods to decontaminate facilities and equipment used to prepare human cellular and tissue products and human birth products including plasma deriviatives.

 

       
Location: HOL - B Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsTransmissible Spongiform Encephalopathies Advisory Committee

Meeting Date: 2/20/03-2/20/03

Meeting Details:

The committee will listen to updates on: implementation of the variant Creutzfeldt-Jakob disease (vCJD) guidance and its affect on blood supply, and an update on bovine spongiform encephalopathy epidemiology and food chain controls. The committee will then discuss consideration of labeling claims for transmissible spongiform encephalopathy (TSE) agent clearance in plasma derivatives.

 

       
Location: Holiday Inn Ballroom Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-5:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsTransmissible Spongiform Encephalopathies Advisory Committee

Meeting Date: 6/26/02-6/27/02

Meeting Details:

On June 26, 2002, the committee will discuss validation of procedures to prevent contamination and cross-contamination with TSE agents of human tissue intended for transplantation. In the afternoon, the committee will discuss the “FDA Draft Guidance on Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Human Cells, Tissues, and Cellular and Tissue-Based Products”. On June 27, 2002 the committee will listen to updates on: implementation of blood donor deferrals for risk of vCJD, recent reports of infectivity detected in blood of sheep experimentally infected with BSE and scrapie agents, and recent reports of abnormal prion proteins and infectivity detected in muscles of experimentally infected mice.

 

       
Location: Gaithersburg Holiday Inn Gaithersburg, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsTransmissible Spongiform Encephalopathies Advisory Committee

Meeting Date: 10/25/01-10/26/01

Meeting Details:

On October 25, 2001, the committee will discuss FDA’s Draft Guidance on Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products. Later that morning the committee will discuss amino acid sourcing and production, and the theoretical risk of transmission of the BSE agent through their use in vaccines, other biologicals and human drugs. On October 26, 2001, the committee will discuss the risk of bovine brains and other neurological tissue for human use.

 

       
Location: HOL - SS Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsTransmissible Spongiform Encephalopathies Advisory Committee

Meeting Date: 6/28/01-6/29/01

Meeting Details:

On June 28, 2001, the committee will review and discuss the suitability of blood donors who have lived or traveled in various countries based on recent information concerning new-variant Creutzfeldt-Jakob disease (vCJD) and bovine spongiform encephalopathy (BSE) in those countries. In the afternoon the committee will discuss the safety of FDA-regulated plasma derivatives prepared in establishments proposing to use both suitable and unsuitable plasma on the same manufacturing line. On June 29, 2001, the committee will discuss the interim results of a new study on the inactivation of TSE agent by the manufacturing process for gelatin.

 

       
Location: Bethesda, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsTransmissible Spongiform Encephalopathies Advisory Committee

Meeting Date: 1/18/01-1/19/01

Meeting Details:

On January 18, 2001, the Committee will discuss whether recent information about new-variant Creutzfeldt-Jakob disease (vCJD) in France and bovine spongiform encephalopathy in France and other European countries suggests a need to reconsider FDA policies on suitability of blood donors who lived or traveled in those countries. In the afternoon the Committee will discuss the risks of Creutzfeldt-Jakob disease (CJD) and vCJD transmission by human cells, tissues and cellular and tissue-based products intended for implantation, transplantation, infusion, or transfer that are currently or proposed to be regulated by FDA, and the possible deferral of donors who have resided in the United Kingdom. On January 19, 2001, the Committee will discuss issues related to deer and elk infected with or exposed to chronic wasting disease in the U.S. and potential for human exposure. In the afternoon the Committee will discuss whether a history of possible exposure to various animal transmissible spongiform encephalopathy agents should be considered by the FDA in determining suitability of blood donors. On January 18, 2001, the Committee will discuss whether recent information about new-variant Creutzfeldt-Jakob disease (vCJD) in France and bovine spongiform encephalopathy in France and other European countries suggests a need to reconsider FDA policies on suitability of blood donors who lived or traveled in those countries. In the afternoon the Committee will discuss the risks of Creutzfeldt-Jakob disease (CJD) and vCJD transmission by human cells, tissues and cellular and tissue-based products intended for implantation, transplantation, infusion, or transfer that are currently or proposed to be regulated by FDA, and the possible deferral of donors who have resided in the United Kingdom. On January 19, 2001, the Committee will discuss issues related to deer and elk infected with or exposed to chronic wasting disease in the U.S. and potential for human exposure. In the afternoon the Committee will discuss whether a history of possible exposure to various animal transmissible spongiform encephalopathy agents should be considered by the FDA in determining suitability of blood donors.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsTransmissible Spogiform Encephalopathies - Workshop

Meeting Date: 9/20/00-9/22/00

Meeting Details:

Sponsors: U.S. Food and Drug Administration Center for Biologics Evaluation and Research (CBER)Center for Devices and Radiological Health (CDRH)Center for Drugs Evaluation and Research (CDER)Center for Food Safety and Applied Nutrition (CFSAN)Center for Veterinary Medicine (CVM) U.S. National Institutes of Health National Institute of Neurological Disorders and Stroke (NINDS) Poster Session - Call for Abstracts - Closing Date: August 4, 2000 Workshop Goals and Objectives: To identify criteria for evaluating tests to diagnose TSEs and to detect TSE agents. To describe the different types of in vivo and in vitro assays for TSE agents in humans and animals. To promote development and validation of TSE diagnostic tests. To discuss tests for prohibited proteins in ruminant feeds to reduce the risk of TSE transmission. To discuss the need to introduce diagnostic tests into regulatory practice. This international workshop will convene representatives from regulatory authorities, national and international standard-setting organizations, and industrial groups who share a need for validated TSE diagnostic tests. Internationally renowned scientists will make oral presentations on approaches to developing TSE diagnostics, and will discuss general guiding principles and performance criteria for diagnostic tests. Beside invited presentations, interested individuals are invited to submit abstracts for poster presentation, which the workshop’s steering committee will review. The workshop proceedings and summary will be published in the open scientific literature. Target Audience: This program will be of interest to anyone with a background in research, regulatory affairs or experience with TSE diagnostic testing and assay design for the detection of TSE agents.

 

       
Location: Lister Hill Conference Center National Institutes of Health Bethesda, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsTransmissible Spogiform Encephalopathies

Meeting Date: 7/27/00-7/27/00

Meeting Details:

On July 27, 2000, from 9:00am to 4:00pm , the meeting is open to the public. In joint session, the committees will discuss bovine spongiform encephalopathy issues related to the manufacture of vaccines, specifically the use of European fetal calf serum in cell banks and viral seeds, and the use of European beef skeletal muscle and other tissues in manufacturing vaccines.

 

       
Location: Holiday Inn Bethesda, MD Related News Links: Not Available
Time: 8:00AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsTransmissible Spogiform Encephalopathies

Meeting Date: 6/1/00-6/2/00

Meeting Details:

On June 1, 2000, the committee will discuss policies for deferral of blood and plasma donors because of their possible exposure to the agent of bovine spongiform encephalopathy (BSE). On June 2, 2000, the committee will discuss the scientific merit of leukoreduction as a method to reduce the theoretical risk of Creutzfeldt-Jakob Disease (CJD) and/or new variant CJD (nvCJD) in blood and blood components for transfusions as well as plasma for manufacture into derivatives. In the afternoon the committee will receive an update on the regulatory status of human dura mater.

 

       
Location: Holiday Inn-Gaithersburg Gaithersburg, MD. Related News Links: Not Available
Time: 8:30AM-5:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsTransmissible Spongiform Encephalopathies

Meeting Date: 12/18/98-12/18/98

Meeting Details:

On December 18, 1998, the committee will discuss possible deferral of blood or plasma donors based on geographical criteria linked to possible foodborne exposure to the agent of Bovine Spongiform Encephalopathy as a measure to reduce the potential for transmission of new variant Creutzfeldt-Jakob Disease (nvCJD) through blood and blood products. The potential effects of such deferrals on the supply of blood and blood products will be considered as part of the committee's deliberations.

 

       
Location: Holiday Inn Bethesda, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel

Meeting Date: 7/30/14-7/31/14

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Meeting Details:

On July 30, 2014, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for the Ablatherm Integrated Imaging device sponsored by EDAP Technomed, Inc. The proposed Indication for Use for the Ablatherm Integrated Imaging device, as stated in the PMA, is as follows: The Ablatherm Integrated Imaging device is intended for the primary treatment of prostate cancer in subjects with low risk, localized prostate cancer. On July 31, 2014, the committee will discuss and make recommendations regarding the classification of Penile Tumescence Monitors, Nephrostomy Catheters, Stimulators for Electrical Sperm Collection, Erectile Dysfunction Devices, and Alloplastic Spermatoceles. These devices are considered preamendments devices since they were in commercial distribution prior to May 28, 1976, when the Medical Devices Amendments became effective. Penile Tumescence Monitors are currently regulated under the heading, ``Monitor, Penile Tumescence,' Product Code LIL, as unclassified under the 510(k) premarket notification authority. Nephrostomy Catheters are currently regulated under the heading, ``Catheter, Nephrostomy,' Product Code LJE, as unclassified under the 510(k) premarket notification authority. Stimulators for Electrical Sperm Collection are currently regulated under the heading, ``Stimulator, Electrical for Sperm Collection,' Product Code LNL, as unclassified under the 510(k) premarket notification authority. Erectile Dysfunction Devices are currently regulated under the heading, ``Device, Erectile Dysfunction,' Product Code LST, as unclassified under the 510(k) premarket notification authority. Alloplastic Spermatoceles are currently regulated under the heading, ``Spermatocele, Alloplastic,' Product Code LQS, as unclassified under the 510(k) premarket notification authority. FDA is seeking committee input on the safety and effectiveness and the regulatory classification of Penile Tumescence Monitors, Nephrostomy Catheters, Stimulators for Electrical Sperm Collection, Erectile Dysfunction Devices, and Alloplastic Spermatoceles.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 8/1/14-8/1/14

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Meeting Details:

On August 1, 2014, the committee will discuss, make recommendations and vote on information regarding the premarket application (PMA) for the TissuGlu Surgical Adhesive device sponsored by Cohera Medical, Inc. The proposed indication for use for the TissuGlu Surgical Adhesive device, as stated in the PMA is as follows: TissuGlu Surgical Adhesive is indicated for the approximation of tissue layers where subcutaneous dead space exists between the tissue planes in large flap surgical procedures such as abdominoplasty.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsConfidentiality of Interim Results in Cardiovascular Outcome Safety Trials

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

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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 OptionsMeeting OptionsMeeting OptionsPulmonary-Allergy Drugs AdComm

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

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Meeting Details:

he committee will discuss the new drug application (NDA) 21936, for tiotropium bromide inhalation spray, submitted by Boehringer Ingelheim Pharmaceuticals, Inc. for the long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD) and for reducing COPD exacerbations. The discussion will include efficacy data, including the data to support the claim for reduction of COPD exacerbations, but the focus will be on safety findings from the clinical development program and the results of a large safety trial comparing tiotropium bromide inhalation spray and tiotropium bromide inhalation powder.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsNonprescription Drugs AdComm

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

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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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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm

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

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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 OptionsMeeting OptionsMeeting OptionsMethodological Considerations in Evaluation of Cancer

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

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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 OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs

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

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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 OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AC

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

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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 Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsBone, Reproductive and Urologic Drugs AdComm

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

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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 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 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    
Materials:
   
       

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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel

Meeting Date: 7/30/14-7/31/14

Meeting Details:

On July 30, 2014, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for the Ablatherm Integrated Imaging device sponsored by EDAP Technomed, Inc. The proposed Indication for Use for the Ablatherm Integrated Imaging device, as stated in the PMA, is as follows: The Ablatherm Integrated Imaging device is intended for the primary treatment of prostate cancer in subjects with low risk, localized prostate cancer. On July 31, 2014, the committee will discuss and make recommendations regarding the classification of Penile Tumescence Monitors, Nephrostomy Catheters, Stimulators for Electrical Sperm Collection, Erectile Dysfunction Devices, and Alloplastic Spermatoceles. These devices are considered preamendments devices since they were in commercial distribution prior to May 28, 1976, when the Medical Devices Amendments became effective. Penile Tumescence Monitors are currently regulated under the heading, ``Monitor, Penile Tumescence,' Product Code LIL, as unclassified under the 510(k) premarket notification authority. Nephrostomy Catheters are currently regulated under the heading, ``Catheter, Nephrostomy,' Product Code LJE, as unclassified under the 510(k) premarket notification authority. Stimulators for Electrical Sperm Collection are currently regulated under the heading, ``Stimulator, Electrical for Sperm Collection,' Product Code LNL, as unclassified under the 510(k) premarket notification authority. Erectile Dysfunction Devices are currently regulated under the heading, ``Device, Erectile Dysfunction,' Product Code LST, as unclassified under the 510(k) premarket notification authority. Alloplastic Spermatoceles are currently regulated under the heading, ``Spermatocele, Alloplastic,' Product Code LQS, as unclassified under the 510(k) premarket notification authority. FDA is seeking committee input on the safety and effectiveness and the regulatory classification of Penile Tumescence Monitors, Nephrostomy Catheters, Stimulators for Electrical Sperm Collection, Erectile Dysfunction Devices, and Alloplastic Spermatoceles.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsObstetrics and Gynecology Devices Panel

Meeting Date: 7/10/14-7/11/14

Meeting Details:

On July 10 and 11, 2014, the committee will discuss the safety of laparoscopic power morcellator devices as it pertains to their potential to disseminate and upstage a confined, but undetected (occult) uterine malignancy during laparoscopic hysterectomy or myomectomy. FDA is convening this committee to seek expert scientific and clinical opinion on the risks and benefits of these types of devices when used for these procedures, based on available scientific data. The committee will make recommendations regarding the appropriate use, premarket testing, labeling, and other risk mitigations (including the use of containment bags) for these devices. On July 11, 2014, during the afternoon session, the committee will also be asked to discuss the regulatory classification of laparoscopic power morcellator devices when used to cut and extract tissue during gynecologic laparoscopic procedures and to assist FDA in determining the appropriate level of regulatory control necessary for this device type, including discussion of class II (special controls) or reclassification to class III (subject to premarket approval application (PMA)).

 

       
Location: FDA White Oak Campus Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Past Meetings

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