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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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 OptionsAnesthetic and Analgesic Drug Products AdComm and the DSRM AdComm

Meeting Date: 5/5/16-5/5/16

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Meeting Details:

The committees will be asked to discuss new drug application (NDA) 208653, benzhydrocodone/acetaminophen oral tablets, submitted by KemPharm, Inc., with the proposed indication of short-term (up to 14 days) management of acute pain. The product has been formulated with the intent to provide abuse-deterrent properties. Benzhydrocodone is a hydrocodone prodrug which, according to the applicant, is rapidly converted into hydrocodone by enzymes in the gastrointestinal tract. The active drugs in this fixed-dose combination are hydrocodone and acetaminophen. The applicant has submitted data to support abuse-deterrent properties for this product. The committees will be asked to discuss whether the applicant has demonstrated abuse-deterrent properties for their product that would support labeling, and whether the nasal route of abuse is relevant for combination products made up of hydrocodone and acetaminophen.

 

       
Location: tbd Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm

Meeting Date: 5/24/16-5/25/16

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Meeting Details:

On May 24th - The committee will discuss the safety and efficacy of new drug application (NDA) 208583 for insulin degludec and liraglutide injection, submitted by Novo Nordisk Inc., for the proposed indication: adjunct to diet and exercise to improve glycemic control in the treatment of adults with type 2 diabetes mellitus. On May 25th - The committee will discuss the safety and efficacy of new drug applications (NDAs) 208673 for insulin glargine and lixisenatide injection, a fixed ratio drug product consisting of insulin and a GLP-1 receptor agonist, and 208471 for lixisenatide injection, a GLP-1 receptor agonist, submitted by Sanofi Aventis c/o Sanofi U.S. Services Inc., proposed for the treatment of adults with type 2 diabetes mellitus.

 

       
Location: TBD Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 5/24/16-5/24/16

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Meeting Details:

On May 24, 2016, the committee will discuss, make recommendations and vote on information related to the premarket approval application regarding St. Jude Medical's AMPLATZER Patent Foramen Ovale (PFO) Occluder. The AMPLATZER PFO Occluder is a percutaneously delivered permanent cardiac implant for PFO closure. The device is indicated for preventing recurrent ischemic stroke in patients who have had a cryptogenic stroke due to a presumed paradoxical embolism.

 

       
Location: Hiton GB Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm

Meeting Date: 5/24/16-5/25/16

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Meeting Details:

On May 24th - The committee will discuss the safety and efficacy of new drug application (NDA) 208583 for insulin degludec and liraglutide injection, submitted by Novo Nordisk Inc., for the proposed indication: adjunct to diet and exercise to improve glycemic control in the treatment of adults with type 2 diabetes mellitus. On May 25th - The committee will discuss the safety and efficacy of new drug applications (NDAs) 208673 for insulin glargine and lixisenatide injection, a fixed ratio drug product consisting of insulin and a GLP-1 receptor agonist, and 208471 for lixisenatide injection, a GLP-1 receptor agonist, submitted by Sanofi Aventis c/o Sanofi U.S. Services Inc., proposed for the treatment of adults with type 2 diabetes mellitus.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 6/2/16-6/3/16

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Meeting Details:

On June 2 and 3, 2016, the committee will discuss recent reports and epidemiologic investigations of nontuberculous mycobacteria (NTM) infections associated with the use of heater-cooler devices during cardiac surgical procedures. FDA is convening this committee to seek expert scientific and clinical opinion related to contamination of heater-cooler devices, associated patient infections, and mitigation strategies based on available scientific information. The committee will make recommendations on: (1) the effectiveness of cleaning and disinfection methods for heater-cooler devices; (2) the amount and type of premarket data and information needed to demonstrate validation of cleaning and disinfection of heater-cooler devices in support of labeling claims and technical instructions; 5 (3) appropriate risk mitigations to be implemented by manufacturers of heater-cooler devices and/or hospital facilities to ensure patient safety during surgical procedures where these devices are used; and (4) appropriate guidelines and/or criteria based on a risk stratification schema for notifying patients who may have already been exposed to NTM during prior cardiac surgeries. Recommendations on these issues will assist FDA in minimizing patient exposure to infections that may result from contaminated heater-cooler devices.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Analgesic Drug Products AdComm and the DSRM AdComm

Meeting Date: 6/7/16-6/7/16

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Meeting Details:

The committees will be asked to discuss new drug application (NDA) 207975, hydrocodone bitartrate extended-release tablets, submitted by Teva Branded Pharmaceutical Products R&D, Inc., with the proposed indication of management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The product is an extended-release formulation intended to have abusedeterrent properties based on its physicochemical properties. The committees will be asked to discuss whether the data submitted by the Applicant are sufficient to support labeling of the product with the properties expected to deter abuse.

 

       
Location: TBD Related News Links: Not Available
Time: 8:00AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Analgesic Drug Products AdComm and the DSRM AdComm

Meeting Date: 6/8/16-6/8/16

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Meeting Details:

The committees will be asked to discuss new drug application (NDA) 207621, oxycodone hydrochloride and naltrexone hydrochloride extended-release capsules, submitted by Pfizer, Inc., with the proposed indication of management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The product is an extended-release formulation intended to have abuse-deterrent properties based on the presence of naltrexone, an opioid antagonist, in the formulation. The committees will be asked to discuss whether the data submitted by the Applicant are sufficient to support labeling of the product with the properties expected to deter abuse.

 

       
Location: TBD Related News Links: Not Available
Time: 8:00AM-2:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint Meeting-Anesthetic and Analgesic Drug Products AC, the DSRM AC, and the Pediatric AC

Meeting Date: 9/15/16-9/16/16

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Meeting Details:

The purpose of this public advisory committee meeting is to discuss the appropriate development plans for establishing the safety and efficacy of prescription opioid analgesics for pediatric patients, including obtaining pharmacokinetic data and the use of extrapolation.

 

       
Location: TBD Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsPeripheral and Central Nervous System Drugs Advisory Committee

Meeting Date: 4/25/16-4/25/16

Meeting Details:

The committee will discuss new drug application (NDA) 206488, eteplirsen injection for intravenous infusion, sponsored by Sarepta Therapeutics, Inc., for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 51 skipping.

 

       
Location: College Park Marriott Hotel and Conference Center Chesapeake Ballroom 3501 University Boulevard East, Hyattsville, MD 20783 Related News Links: Not Available
Time: 8:00AM-5:30PM    
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Meeting OptionsMeeting OptionsMeeting OptionsOrthopaedic and Rehabilitation Devices Panel of the Medical Devices AdComm

Meeting Date: 4/20/16-4/20/16

Meeting Details:

The Committee will discuss, make recommendations, and vote on the premarket approval application for the Cartiva Synthetic Cartilage Implant (SCI), sponsored by Cartiva, Inc. The Cartiva Synthetic Cartilage Implant (SCI) is an organic polymer-based biomaterial to mimic biologic cartilage. The device is to be indicated for treatment of degenerative and post-traumatic arthritis in the first metatarsophalangeal joint in the presence of good bone stock along with the following clinical conditions: hallux valgus or hallux limitus, hallux rigidus, and an unstable or painful metatarsophalangeal joint.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsNonprescription Drugs Advisory Committee Meeting

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

Meeting Details:

The committee will discuss data submitted by Galderma Laboratories, L.P. to support supplemental new drug application (sNDA) 20-380, for over-the-counter (OTC) marketing of adapalene gel 0.1%. The proposed OTC use is for the treatment of acne and to clear up acne pimples and acne blemishes. The applicant proposes to label the product for 12 years and older. The committee will be asked to consider whether data support an acceptable risk/benefit profile for the nonprescription use of adapalene gel 0.1% by OTC consumers.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsPediatric Advisory Committee

Meeting Date: 4/12/16-4/12/16

Meeting Details:

On April 12, 2016, the Pediatric Advisory Committee (PAC) will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (Pub. L. 107-109) and the Pediatric Research Equity Act (Pub. L. 108-155). See the list of the products in this document to be discussed. In addition, FDA will be providing information on a proposed public advisory committee meeting for September 15 and 16, 2016, on appropriate pediatric development plans for prescription opioid drugs. Prior to the safety reviews and the open public hearing (see later in this section for further information), FDA will present, from approximately 8:30 to 9:30 a.m., a framework of current plans for a 2-day joint meeting of the PAC, the Anesthetic and Analgesic Drug Products Advisory Committee, and the Drug Safety and Risk Management Advisory Committees. Elsewhere in this issue of the Federal Register, FDA is publishing an announcement of this advisory committee meeting to be held on September 15 and 16, 2016, on the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993-0002. Following the presentation on the proposed framework for the September meeting, there will be an hour of open public hearing from 9:30 a.m. to 10:30 a.m. to provide an opportunity for the public to provide input concerning the topics before the PAC, including the use of opioids for control of severe pain in the pediatric population. To assist with the planning of this advisory committee meeting, FDA is establishing a public docket [Docket No. FDA-2016-N-0584] to receive input on appropriate pediatric development plans for prescription opioid drugs. The docket will remain open following the September advisory committee meeting. Comments about the upcoming September advisory committee meeting should not be submitted to the docket number listed at the top of this Federal Register notice [Docket No. FDA-2016-N-0567]. Please also see the ADDRESSES section of this notice for further docket information. The pediatric-focused safety reviews for the Centers will then occur. The PAC will meet to discuss the following products (listed by FDA Center): Center for Biologics Evaluation and Research (CBER): [cir] FLULAVAL QUADRIVALENT (influenza virus vaccine) [cir] FLULAVAL TRIVALENT (influenza virus vaccine) [cir] FLUZONE QUADRIVALENT (influenza virus vaccine) Center for Drug Evaluation and Research (CDER): [cir] ACIPHEX SPRINKLES (rabeprazole sodium) [cir] SKYLA (levonorgestrel-releasing intrauterine system) [cir] MYCAMINE (micafungin sodium) [cir] NOXAFIL (posaconazole) [cir] PRECEDEX (dexmedetomidine hydrocholoride) [cir] SABRIL (vigabatrim) [cir] SEROQUEL (quetiapine fumarate) and SEROQUEL XR (quetiapine fumarate extended-release) [[Page 8509]] [cir] SKYLA (levonorgestrel-releasing intrauterine system) [cir] SYMBAX (fluoxetine hydrocholoride and olanzapine) [cir] VYVANSE CAPSULES (lisdexamfetamine dimesylate) [cir] XELODA (capecitabine) Center for Devices and Radiological Health (CDRH): [cir] IMPELLA RP SYSTEM (humanitarian use device (HUD)) [cir] LIPSORBER LA-15 SYSTEM (HUD) [cir] MEDTRONIC ACTIVA DYSTONIA THERAPY (HUD) In addition to the agenda items, the PAC will remain in public session over the lunch hour on April 12, 2016, to hear a presentation and provide feedback on an FDA proposal for a risk-based approach to the pediatric-focused safety reviews mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. The working lunch currently is scheduled between approximately 12:30 p.m. and 1:15 p.m.

 

       
Location: DoubleTree Bethesda 8120 Wisconsin Avenue Bethesda, MD 20814 Related News Links: Not Available
Time: 8:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Advisory Committee Meeting

Meeting Date: 4/12/16-4/12/16

Meeting Details:

The committee will discuss new drug application (NDA) 208542 rociletinib tablets, application submitted by Clovis Oncology, Inc. The proposed indication (use) for this product is for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation as detected by an FDA approved test.

 

       
Location: TBD Related News Links: Not Available
Time: 8:30AM-1:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs AdComm

Meeting Date: 4/7/16-4/7/16

Meeting Details:

The committee will discuss new drug application (NDA) 207999, obeticholic acid oral tablets, submitted by Intercept Pharmaceuticals, Inc., proposed for the treatment of primary biliary cirrhosis in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.

 

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

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