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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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 OptionsEndocrinologic and Metabolic Drugs Advisory Committee

Meeting Date: 6/28/16-6/28/16

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Meeting Details:

The committee will discuss supplemental new drug application (sNDA) 204629 for empagliflozin (JARDIANCE) tablets and sNDA 206111 for empagliflozin and metformin hydrochloride (SYNJARDY) tablets. Both sNDAs are sponsored by Boehringer Ingelheim Pharmaceuticals, Inc., for the proposed additional indication in adult patients with type 2 diabetes mellitus and high cardiovascular risk to reduce the risk of all-cause mortality by reducing the incidence of cardiovascular death and to reduce the risk of cardiovascular death or hospitalization for heart failure.

 

       
Location: Hilton Washington DC/Rockville Rockville, MD 20852 Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPediatric Subcommittee of the Oncologic Drugs Advisory Committee

Meeting Date: 6/28/16-6/28/16

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Meeting Details:

On June 28, 2016, information will be presented for expert assessments related to exploring potential pediatric development plans for four products in various stages of development for adult cancer indications. The subcommittee will consider and discuss issues concerning diseases to be studied, patient populations to be included, and possible study designs in the development of these products for pediatric use. The discussion will also provide information to the Agency pertinent to the formulation of written requests for pediatric studies, if appropriate. The products under consideration are: (1) venetoclax, presentation by AbbVie, Inc. (2) tazemetostat, presentation by Epizyme, Inc., and (3) atezolizumab, presentation by Roche/Genentech.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPediatric Subcommittee of the Oncologic Drugs Advisory Committee

Meeting Date: 6/29/16-6/29/16

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Meeting Details:

On June 29, 2016, during the morning session, information will be presented for expert assessments related to exploring potential pediatric development plans for two products in various stages of development for adult cancer indications. The subcommittee will consider and discuss issues concerning diseases to be studied, patient populations to be included, and possible study designs in the development of these products for pediatric use. The discussion will also provide information to the Agency pertinent to the formulation of written requests for pediatric studies, if appropriate. The products under consideration are: (1) LOXO-101, presentation by Loxo Oncology, Inc., and (2) entrectinib, presentation by Ignyta, Inc.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-4:30AM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsArthritis Advisory Committee

Meeting Date: 7/12/16-7/12/16

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Meeting Details:

The committee will discuss biologics license application 761024, for ABP 501, a proposed biosimilar to AbbVie Inc.'s HUMIRA (adalimumab), submitted by Amgen, Inc. The proposed indications (uses) for this product are: (1) Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis (alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs)); (2) reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 4 years of age and older (alone or in combination with methotrexate); (3) reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis (alone or in combination with non-biologic DMARDs); (4) reducing signs and symptoms in adult patients with active ankylosing spondylitis; (5) reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy (ABP 501 would be indicated for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab); (6) inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine or 6-mercaptopurine (6-MP) (the effectiveness of ABP-501 would not be established in patients who have lost response to or were intolerant to TNF blockers); and (7) treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate (only to be administered to patients who will be closely monitored and have regular follow-up visits with a physician).

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 7:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsArthritis Advisory Committee

Meeting Date: 7/13/16-7/13/16

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Meeting Details:

The committee will discuss biologics license application 761042, for GP2015, a proposed biosimilar to Amgen Inc.’s ENBREL (etanercept) submitted by Sandoz, Inc. The proposed indications (uses) for this product are: (1) Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis (in combination with methotrexate (MTX) or used alone); (2) reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients ages 2 and older; (3) reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with psoriatic arthritis (in combination with MTX in patients who do not respond adequately to MTX alone); (4) reducing signs and symptoms in patients with active ankylosing spondylitis; and (5) treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 7:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsDermatologic and Ophthalmic Drugs Advisory Committee

Meeting Date: 7/19/16-7/19/16

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Meeting Details:

The committee will discuss biologics license application (BLA) 761032, brodalumab injection, a human monoclonal antibody, submitted by Valeant Pharmaceuticals Luxembourg S.à.r.l, proposed for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsClinical Chemistry and Clinical Toxicology Devices Panel of the MDAC

Meeting Date: 7/21/16-7/22/16

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Meeting Details:

On July 21, 2016, the committee will discuss, make recommendations, and vote on information regarding a premarket approval application (PMA) panel-track supplement for a proposed change in intended use of Dexcom, Inc.’s, Dexcom G5® Mobile Continuous Glucose Monitoring System (CGM) device so that, in addition to tracking and trending interstitial fluid glucose concentrations, patients can use the device as a replacement for their blood glucose meters and make treatment decisions based on the interstitial fluid glucose concentration reported by the CGM.
On July 22, 2016, the committee will discuss and make recommendations on information regarding a premarket notification (510(k)) submission for the Alere Afinion™ HbA1c Dx point-of-care test system, sponsored by Alere Technologies AS. The proposed intended use, as stated by the sponsor: Alere Afinion HbA1c Dx is an in vitro diagnostic test for quantitative determination of glycated hemoglobin (% hemoglobin A1c, HbA1c) in human whole blood. This test is to be used as an aid in the diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes. The measurement of % HbA1c is recommended as a marker of long-term metabolic control in persons with diabetes mellitus. For use in clinical laboratories and point of care laboratory settings.

 

       
Location: Hilton Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCellular, Tissue, and Gene Therapies Advisory Committee

Meeting Date: 7/26/16-7/26/16

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Meeting Details:

On July 26, 2016, the committee will meet by teleconference. In open session, the committee will hear updates of research programs in the Laboratory of Molecular Oncology and the Laboratory of Biological Chemistry, Division of Biotechnology Review and Research 1 and 4, Office of Biotechnology Products (OBP), Center for Drug Evaluation and Research, FDA.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 1:00PM-3:30PM    
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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 OptionsPharmacy Compounding Advisory Committee

Meeting Date: 6/23/16-6/23/16

Meeting Details:

The committee intends to discuss six bulk drug substances nominated for inclusion on the section 503A bulk drug substances list. FDA intends to discuss the following nominated bulk drug substances: chrysin, cesium chloride, sodium dichloroacetate, pyruvic acid, tea tree oil, and 2,3-Dimercapto-1-propanesulfonic acid (DMPS). The nominators of these substances will be invited to make a short presentation supporting the nomination. During the afternoon session, the committee will receive updates on certain issues to follow up on discussions from previous meetings, including the option for obtaining access to investigational new drugs under expanded access.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:30AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsBlood Products Advisory Committee

Meeting Date: 6/20/16-6/20/16

Meeting Details:

On June 20, 2016, the Committee members will participate in the meeting via teleconference. In open session, the Committee will discuss the research programs in the Laboratory of Plasma Derivatives in the Division of Hematology Research and Review, Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 9:30AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsAntimicrobial Drugs Advisory Committee

Meeting Date: 6/9/16-6/9/16

Meeting Details:

The committee will discuss biologics license application (BLA) 761046, bezlotoxumab (MK-6072) injection, submitted by Merck Sharpe & Dohme Corp., for the proposed indication of prevention of Clostridium difficile infection recurrence.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:30AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsJoint Anesthetic and Analgesic Drug Products AdComm and the DSRM AdComm

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

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: FDA White Oak Related News Links: Not Available
Time: 9:30AM-2:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Anesthetic and Analgesic Drug Products AdComm and the DSRM AdComm

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

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: 9:30AM-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

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

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; (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 OptionsEndocrinologic and Metabolic Drugs AdComm (Sanofi Aventis)

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

Meeting Details:

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

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