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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products AdComm

Meeting Date: 3/4/16-3/4/16

Meeting Details:

On March 4, 2016, the committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2016-2017 influenza season.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:30AM-3:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products AdComm

Meeting Date: 11/13/15-11/13/15

Meeting Details:

The committee will meet in open session to discuss considerations for evaluation of the safety and effectiveness of vaccines administered to pregnant women to protect the infant.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-2:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products Advisory

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

Meeting Details:

The committee will meet in open session to discuss and make recommendations on the safety and immunogenicity of Seasonal Trivalent Influenza Vaccine, Surface Antigen, Inactivated, Adjuvanted with MF59 (FLUAD) manufactured by Novartis.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-3:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products

Meeting Date: 3/4/15-3/4/15

Meeting Details:

On March 4, 2015, from 8:30 a.m. to 3 p.m., the committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2015-2016 influenza season.

 

       
Location: Hilton - Silver Spring, MD Related News Links: Not Available
Time: 8:30AM-3:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products

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

Meeting Details:

On February 27, 2013, the committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccine for the 2013-2014 influenza season.

 

       
Location: Fishers Building Related News Links: Not Available
Time: 8:30AM-2:45PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products Advisory Committee

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

Meeting Details:

On November 16, 2011, the committee will meet in open session to hear an overview of the research program in the Laboratory of Method Development, Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. The committee will also hear an update on the evaluation of Gullian-Barre Syndrome after Influenza Vaccine among Medicare population, 2010-2011. The committee will then discuss and make recommendations on the safety and immunogenicity (surrogate endpoint) of Pneumococcal 13-valent conjugate vaccine (Diphtheria CRM197 Protein) in adults aged 50 years and older using an accelerated approval regulatory pathway.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsCancelled - Vaccines and Related Biological Products AdComm

Meeting Date: 9/20/11-9/20/11

Meeting Details:

On September 20, 2011, the committee will meet in open session to hear an overview of the research program in the Laboratory of Enteric and Sexually Transmitted Diseases, Division of Bacterial, Parasitic and Allergenic Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. The committee will then discuss and make recommendations on the safety and immunogenicity (surrogate endpoint) of Pneumococcal 13-valent conjugate vaccine (Diphtheria CRM197 Protein) in adults aged 50 years and older using an accelerated approval regulatory pathway.

 

       
Location: Gaithersburg Hilton Hotel Related News Links: Not Available
Time: 8:00AM-5:15PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products

Meeting Date: 4/6/11-4/7/11

Meeting Details:

On the morning of April 6, 2011, the committee will meet in open session to hear updates of the research programs in the Laboratory of Bacterial Polysaccharides, Division of Bacterial, Parasitic, & Allergenic Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. In the afternoon of April 6, 2011, the committee will meet in open session and will be briefed on the use of immunological markers for demonstration of effectiveness of meningococcal serogroups A,C,Y and W-135 conjugate vaccines administered to children less than 2 years of age. On April 7, 2011, the committee will meet in open session to review and discuss approaches to licensure of meningococcal serogroup B vaccines.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products AdComm

Meeting Date: 2/25/11-2/25/11

Meeting Details:

On February 25, 2011, the committee will discuss and make recommendations on the selection of strains to be included in the influenza virus vaccine for the 2011-2012 influenza season. The committee will also hear an update on Pandemic Influenza Surveillance.

 

       
Location: DoubleTree Hotel Bethesda and Executive Meeting Center, 8120 Wisconsin Ave., Bethesda, MD 20814. Related News Links: Not Available
Time: 8:30AM-2:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products

Meeting Date: 11/16/10-11/17/10

Meeting Details:

On November 16, 2010, the committee will meet in open session to review and discuss the pathway to licensure for protective antigen-based anthrax vaccines for a post-exposure prophylaxis indication using the animal rule. On November 17, 2010, the committee will meet in open session to review and discuss the effectiveness of vaccinating males and females with Gardasil manufactured by Merck & Co. for the prevention of anal dysplasia and anal cancer.

 

       
Location: Hilton Silver Spring, MD Related News Links: Not Available
Time: 8:30AM-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products AdComm

Meeting Date: 5/7/10-5/7/10

Meeting Details:

On May 7, 2010, in the morning, the committee will review and discuss available data regarding the unexpected finding of DNA originating from porcine circovirus type 1 (PCV 1) in Rotarix, a U.S. licensed vaccine manufactured by GlaxoSmithKline and indicated for the prevention of rotavirus gastroenteritis in infants. The committee will discuss what additional steps should be considered to address this finding. In the afternoon, the committee will discuss and make recommendations on the use of advanced analytical detection methods not currently applied for the characterization of cell substrates, viral seeds, and other biological materials used in the production of viral vaccines for human use.

 

       
Location: Hilton Hotel DC North/Gaithersburg 620 Perry Pkwy Gaithersburg, Maryland 20877 Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products AdComm

Meeting Date: 2/22/10-2/22/10

Meeting Details:

The committee will discuss and make recommendations on the selection of strains to be included in the influenza virus vaccine for the 2010 - 2011 influenza season.

 

       
Location: Bethesda Marriott Related News Links: Not Available
Time: 8:30AM-1:30AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products AdComm

Meeting Date: 11/18/09-11/19/09

Meeting Details:

In open session on November 18, 2009, the committee will discuss and make recommendations on the safety and effectiveness of a Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein), BLA 125324, and will hear an update on FDA's Influenza A (H1N1) 2009 monovalent vaccine activities; Postmarketing surveillance. On November 19, 2009, the committee will discuss and make recommendations on the safety and effectiveness of an Influenza Vaccine, Purified Recombinant Influenza Hemagglutinin, BLA STN125285.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-5:45PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products AdComm

Meeting Date: 9/9/09-9/9/09

Meeting Details:

On September 9, 2009, in the morning, the committee will discuss and make recommendations on the safety and effectiveness in females of a vaccine manufactured by GlaxoSmithKline against Human Papillomavirus. In the afternoon, the committee will discuss and make recommendations on the safety and effectiveness of vaccinating males with Gardasil, a vaccine manufactured by Merck & Co. against Human Papillomavirus.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products AdComm

Meeting Date: 7/23/09-7/23/09

Meeting Details:

The committee will discuss clinical trials to support use of vaccines against the 2009 H1N1 influenza virus.

 

       
Location: Hilton Gaithersburg MD Related News Links: Not Available
Time: 8:00AM-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products AdComm

Meeting Date: 2/18/09-2/19/09

Meeting Details:

On February 18, 2009, in the morning, the committee will discuss and make recommendations on the selection of strains to be included in the influenza virus vaccine for the 20092010 influenza season and in the afternoon will discuss the utility of adding a second B strain to current seasonal influenza vaccines. On February 19, 2009, the committee will discuss the conducting of clinical studies of pandemic influenza vaccine in the pediatric population in the absence of an influenza pandemic.

 

       
Location: Hilton - GB Related News Links: Not Available
Time: 8:30AM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products AdComm

Meeting Date: 9/25/08-9/25/08

Meeting Details:

In open session the Committee will be briefed on the Office of Vaccine's Research and Review (OVRR), Center for Biologics Evaluation and Research (CBER) response to OVRR Office Site Visit Review Report that was presented and approved by this committee on January 25, 2007. The Committee will also hear presentations and hold discussion on the use of Madin-Darby canine kidney (MDCK) Cells for manufacture of live attenuated Influenza Virus Vaccines.

 

       
Location: Crowne Plaza Hotel 8777 Georgia Ave. Silver Spring, MD 20910 Related News Links: Not Available
Time: 8:30AM-4:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products AdComm

Meeting Date: 2/20/08-2/21/08

Meeting Details:

On February 20, 2008, the committee will discuss and make recommendations on a rotavirus vaccine manufactured by GlaxoSmithKline Biologicals. On February 21, 2008, in the morning, the committee will discuss the selection of strains to be included in the influenza vaccine for the 2008 - 2009 influenza season. In the afternoon, the committee will discuss clinical development of influenza vaccines for pandemic and pre-pandemic uses.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products AdComm

Meeting Date: 5/16/07-5/17/07

Meeting Details:

On May 16,2007, in the morning session, the committee will hear presentations and make recommendations on the safety and effectiveness of influenza virus vaccine live (FluMist) in a pediatric population less than 59 months of age, manufactured by MedIrnmune Vaccines, Inc. In the afternoon, the committee will hear an overview of the function of the Laboratory of Bacterial Polysaccharides and the Laboratory of Enteric & Sexually Transmitted Diseases, Division of Bacterial Parasitic and Allergenic Products, Office of Vaccines Research and Review, CBER and in closed session will discuss the report of the November 29, 2006, laboratory site visit. On May 17, 2007, the committee will hear presentations and make recommendations on the safety and immunogenicity of a live vaccinia virus smallpox vaccine (ACAM2000) manufactured by Acambis, Inc.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products AdComm

Meeting Date: 2/27/07-2/28/07

Meeting Details:

On February 27, 2007, in the morning session, the committee will hear presentations and make recommendations on the safety and effectiveness of an H5N1 inactivated influenza vaccine manufactured by Sanofi Pasteur. In the afternoon, the committee will hear presentations and have discussions on clinical development of influenza vaccines for pre-pandemic uses. On February 28, 2007, in the morning, the committee will hear presentations and make recommendations on strain selections for the influenza virus vaccine for the 2007-2008 season. In the afternoon, the committee will hear presentations and have discussions on circulating lineages of influenza type B virus.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products AdComm

Meeting Date: 1/25/07-1/25/07

Meeting Details:

In Session I, the committee will hear presentations and make recommendations on the safety and immunogenicity of Diphtheria & Tetanus Toxoids & Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined (DTaP-IPV/Hib), PENTACEL, manufactured by Sanofi Pasteur Limited and in Session II, will hear an overview of the research programs in the Office of Vaccines Research and Review, CBER. In closed session, the committee will discuss the report of the Office of Vaccines Research and Review Office Site Visit of May 19, 2006.

 

       
Location: TBA Related News Links: Not Available
Time: 8:00AM-4:25PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsVRBAC Research Review Subcommittee

Meeting Date: 5/19/06-5/19/06

Meeting Details:

The subcommittee will listen to presentations about the research program at the Office of Vaccines Research and Review (OVRR). The program is intended to provide dynamic, responsive, cutting edge research to contribute to OVRR' regulatory mission and facilitate development of safe and effective biological products. The subcommittee will discuss the program and make recommendations that will be publicly discussed at a future meeting of the Vaccines and Related Biological Products Advisory Committee.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-2:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsVRBAC Meeting

Meeting Date: 5/18/06-5/18/06

Meeting Details:

The committee will hear presentations and make recommendations on the safety and efficacy of GARDASIL® (Human Papillomavirus [Types 6,11,16,18] Recombinant Vaccine) manufactured by Merck.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 9:00AM-4:45PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products AdComm

Meeting Date: 2/17/06-2/17/06

Meeting Details:

The committee will review and discuss the selection of strains to be included in the influenza virus vaccine for the 2006-2007 season.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 1:00PM-5:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products AdComm

Meeting Date: 12/14/05-12/15/05

Meeting Details:

On December 14, 2005 the committee will hear presentations and make recommendations on the safety and efficacy of a rotavirus vaccine manufactured by Merck. On December 15, 2005, the committee will hear presentations and make recommendations on the safety and efficacy of ZOSTAVAX (zoster vaccine live (Oka/Merck)) manufactured by Merck.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products AdComm

Meeting Date: 11/16/05-11/17/05

Meeting Details:

On November 16, 2005, the committee will hear presentations and discuss the use of Madin-Darby Canine Kidney Cells for manufacture of Inactivated Influenza Vaccines. On November 17, 2005, the committee will discuss developing new Pneumococcal Vaccines for U.S. licensure for adults.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products

Meeting Date: 3/15/05-3/15/05

Meeting Details:

The committee will review safety and immunogenicity for two Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Absorbed (Tdap) vaccines. In the morning the committee will review safety and immunogenicity data for Tdap vaccine manufactured by GlaxoSmithKline Biologicals. In the afternoon the committee will review safety and immunogenicity data for Tdap vaccine manufactured by Aventis Pasteur Ltd.

 

       
Location: Holiday Inn Select Bethesda 8120 Wisconsin Ave. Bethesda, MD Related News Links: Not Available
Time: 8:30AM-5:40PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products Advisory Committee

Meeting Date: 2/16/05-2/17/05

Meeting Details:

On February 16, 2005 the committee will review and discuss the selection of strains to be included in the influenza virus vaccine for the 2005 – 2006 season. On February 17, 2005, the committee will hear updates on FDA Critical Path Initiative and Research Programs in the Center for Biologics Evaluation and Research.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Blood Products Advisory Committee

Meeting Date: 9/22/04-9/23/04

Meeting Details:

The committee will consider on Sept 22nd the Safety and Efficacy of Menactra by Aventis Pasteur. On Sept 23 the committee will hear an update on the Phase III trial of ALVAC BCP 1521 (check on it) with AIDSVACS for the prevention of HIV Infection. Oral Presentations for the public will be scheduled btwn approx 2 - 2:30 on Sept 22 and btwn approx 10:15 and 10:45 on Sept 23rd. Those desiring to make formal oral presentations please notify the contact person before Sept 16th.

 

       
Location: Holiday Inn Select Bethesda Related News Links: Not Available
Time: 8:15AM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products Advisory Committee

Meeting Date: 2/18/04-2/19/04

Meeting Details:

The committee will review and discuss the selection of strains to be included in the influenza virus vaccine for the 2004-2005 season. The committee and CBER will begin a discussion of the potential suitability for use in vaccine manufacture of influenza isolates that have been passaged through mammalian cells (e.g., MDCK cells or Vero cells).

 

       
Location: Sheraton Four-Points Hotel Bethesda, MD Related News Links: Not Available
Time: 8:30AM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products Advisory Committee

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

Meeting Details:

The committee will review and discuss the selection of strains to be included in the influenza virus vaccine for the 2003-2004 season and the intramural research program of the Laboratory of Bacterial Polysaccharides (LBP), Office of Vaccines Research and Review (OVRR).

 

       
Location: Holiday Inn 8120 Wisconsin Avenue Bethesda, MD Related News Links: Not Available
Time: 8:30AM-4:30PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines & Related Biological Products Ad Comm

Meeting Date: 12/17/02-12/17/02

Meeting Details:

The committee will review and discuss safety and efficacy and proposed indications for the product FluMist, a cold-adapted, live attenuated, trivalent influenza vaccine for the prevention of influenza sponsored by MedImmune Vaccines, Inc.

 

       
Location: Marriott Bethesda, Md. Related News Links: Not Available
Time: 8:30AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines & Related Biogical Products

Meeting Date: 5/21/02-5/21/02

Meeting Details:

In the morning the committee will discuss acute otitis media indication for Prevnar® (Pneumococcal 7-valent Conjugate Vaccine). In the afternoon the FDA will present an update to the committee on the GSK Lyme Disease Vaccine (LYMErix™).

 

       
Location: Hilton Hotel Silver Spring, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Committee

Meeting Date: 1/30/02-1/30/02

Meeting Details:

On January 30, 2002, the committee will discuss the influenza virus vaccine formulation for the 2002-2003 season.

 

       
Location: Holiday Inn Bethesda, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products Advisory Committee

Meeting Date: 11/28/01-11/29/01

Meeting Details:

On November 28-29, 2001, the committee will review issues surrounding efficacy trial endpoints for Vaccines for the prevention of Human Papilloma Virus. On November 29, 2001, the committee will discuss the intramural scientific research of the Laboratory of Bacterial Toxins.

 

       
Location: Bethesda, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products

Meeting Date: 7/26/01-7/27/01

Meeting Details:

On July 26, the committee will hear presentations on the available safety and efficacy data for Aviron Inc.'s cold adapted, live attenuated, trivalent influenza virus vaccine (FluMista). On July 27, the committee will discuss the available data and the proposed indications for FluMista.

 

       
Location: Holiday Inn Gaithersburg, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products Advisory Committee

Meeting Date: 5/16/01-5/17/01

Meeting Details:

On May 16, 2001, the committee will discuss adventitious agent testing, tumorigenicity testing, and issues related to residual cell substrate DNA of novel and neoplastic cell substrates used to manufacture viral vaccines.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products Advisory Committee

Meeting Date: 3/7/01-3/9/01

Meeting Details:

On March 7, 2001, the committee will review safety and immunogenicity data for a combination vaccine, DTaP-Hepatitis B-IPV, manufactured by SmithKline Beecham Biologicals. On March 8, 2001, the committee will discuss approaches to develop new pneumococcal conjugate vaccines for U.S. licensure. On March 9, 2001, the committee will complete recommendations pertaining to the influenza virus vaccine formulations for the 2001 and 2002 season and be briefed on research programs in the Laboratory of Retroviruses and the Laboratory of Immunoregulation.

 

       
Location: Bethesda, MD Related News Links: Not Available
Time: 3:00AM-7:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products Advisory Committee

Meeting Date: 1/30/01-1/31/01

Meeting Details:

On January 30, 2001, the Committee will discuss the influenza virus vaccine formulation for the 2001-2001 season. On Jauary 31, 2001, the Committee will hear a review of LYMErix (Lyme disease vaccine, SmithKline Beecham) safety profile including an update of post-marketing safety data.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products

Meeting Date: 11/3/00-11/3/00

Meeting Details:

On November 3, 2000, the Committee will hear a brief update on issues relating to transmissible spongiform encephalopathy and will review safety and efficacy data pertaining to a diphtheria/tetanus/acellular pertussis vaccine manufactured by Aventis Pasteur Limited.

 

       
Location: Holiday Inn Bethesda, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products

Meeting Date: 5/11/00-5/12/00

Meeting Details:

On May 11, 2000, the committee will hear updates on activities in the Office of Vaccines Research and Review. The committee will also be informed of issues pertaining to the status of vaccines for the prevention of rotavirus disease. On May 12, 2000, the committee will review issues related to the development of policy regarding the use of various types of neoplastic cells as substrates for vaccine manufacture.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products

Meeting Date: 3/9/00-3/10/00

Meeting Details:

Meeting Cancelled!!!...........Call for more details....................On March 9, the committee was to discuss the safety and efficacy of a combination vaccine from SmithKline Beecham for the prevention of Diphtheria, Tetanus, Pertussis, Polio, and Hepatitis B. On March 10, the committee will complete recommendations pertaining to the influenza virus vaccine formulation for the 2000-2001 season; hear a short briefing on the Vaccine Safety Action Plan; and be updated on the status of vaccines for the prevention of rotavirus disease.

 

       
Location: Holiday Inn Silver Spring, Md Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products

Meeting Date: 1/27/00-1/28/00

Meeting Details:

On January 27, the committee will review the current understanding of the immune correlates of protection against invasive Haemophilus influenzae type b disease and discuss the potential clinical significance of reduced antibody responses to PRP (polyribitol phosphate) polysaccharide following administration of combination vaccines containing Haemophilus influenzae type b conjugate vaccines. On January 28, the committee will discuss the influenza virus vaccine formulation for the 2000-2001 season and be briefed on selected individual research programs in the Laboratory of Pediatric and Respiratory Viral Diseases.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products

Meeting Date: 11/4/99-11/5/99

Meeting Details:

On the morning of November 4, 1999 the committee will discuss ways to demonstrate attenuation of chimeric strains of Cytomegaloviral candidate vaccines to support proceeding into clinical trials. In the afternoon, the committee will discuss safety data following a fifth successive dose of DTaP (Tripedia)manufactured by Connaught Laboratories, Inc. On November 5, 1999 the product license application for Wyeth Lederle Vaccines and Pediatrics' Pneumococcal 7-Valent Conjugate Vaccine (Diphtheria CRM197 protein) will be discussed for use in infants and young children. The committee will be asked to consider the safety and efficacy of this vaccine against prevention of invasive disease (bacteremia and meningitis) caused by Streptococcus pneumoniae (pneumococcus).

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products

Meeting Date: 9/14/99-9/15/99

Meeting Details:

On September 14, 1999 the committee will discuss data relating to a fifth successive dose of a DTaP vaccine manufactured by SmithKline Beecham. The committee will also hear reports on recent workshops on Thimerosal in Vaccines and Cell Substrates for Vaccine Development and be updated on recent developments concerning the rotavirus vaccine manufactured by Wyeth Laboratories, Inc. The committee will also be briefed on selected individual research programs in the Laboratory of Parasitic Biology and the Laboratory of Biophysics. On September 15, 1999 the committee will discuss the use of immunologic surrogates for demonstration of protective efficacy of meningococcal cojugate vaccines.

 

       
Location: Holiday Inn Versailles Ballrooms I and II 8120 W Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products

Meeting Date: 1/29/99-1/29/99

Meeting Details:

The committee will discuss the influenza virus vaccine formulation for 1999-2000. The committee will also hear an update on the status of influenza A H5N1 viruses.

 

       
Location: Holiday Inn Versailles III & IV Bethesda, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products

Meeting Date: 11/19/98-11/20/98

Meeting Details:

Meeting is closed to the public from 8:45 a.m. to 6:30 p.m. on November 19, 1998 to discuss industry trade secrets. Click back in the near future for more information!

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products

Meeting Date: 5/26/98-5/27/98

Meeting Details:

On May 26, in open session, the committee will consider the safety and efficacy of a new vaccine from SmithKline for the prevention of Lyme disease. On May 27, the comittee will consider the safety and efficacy of a live, oral, attenuated vaccine for the prevention of cholera, and discuss issues relating to the potential inclusion of boxed warnings on package inserts, such as for live polio virus vaccine.

 

       
Location: Ramada Inn, Bethesda, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products

Meeting Date: 3/23/98-3/23/98

Meeting Details:

The Committee will discuss scientific and ethical considerations of a human challenge model using virulent Salmonella typhi bacteria. The Committee will also complete decisions pertaining to the influenza virus vaccine formulation for 1998-1999 and hear short briefings on research programs in the Laboratory of DNA Viruses, the Laboratory of Hepatitis Viruses and the Laboratory of Bacterial Polysaccharides.

 

       
Location: Ramada Inn, Bethesda, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines & Related Biological Products

Meeting Date: 12/12/97-12/12/97

Meeting Details:

On December 11, 1997, the committee will meet in closed session to discuss trade secret and/or confidential commercial information relevant to pending investigational new drug applications or pending product licensing applications. On December 12, 1997, in open session, the committee will consider the safety and efficacy of a new vaccine for the prevention of Rotavirus Diarrhea in children. The vaccine, RotaShield, is made for infant indication by Wyeth-Lederle Vaccines and Pediatrics.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products Advisory Committee

Meeting Date: 6/5/97-6/5/97

Meeting Details:

On June 5, 1997, the committee will consider the safety and efficacy of a combination vaccine for infant indication consisting of Haemophilus b conjugate reconstituted with Diphtheria/tetanus/acellular pertussis at the time of administration. The committee will also consider issues pertaining to the use of vaccines for the prevention of pertussis in adults.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products

Meeting Date: 1/30/97-1/30/97

Meeting Details:

The committee will discuss the influenza virus vaccine formulation for 1997-1998. The committee will also hear briefings on a research program in the Division of Bacterial Products and on recent activities in the Center for Biologics Evaluation and Research.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines & Related Biological Products

Meeting Date: 10/29/96-10/30/96

Meeting Details:

On October 29, 1996, the committee will review safety and efficacy data pertaining to diphtheria/tetanus/ acellular pertussis vaccines manufactured by Amvax, Inc., and Lederle Laboratories. On October 30, 1996, the committee will review the possibility of using animal challenge studies (and the design of such studies), in addition to human neutralizing antibody data, to support the efficacy of the botulinum toxoid vaccine. The committee will also hear a briefing on a research program in the Division of Viral Products and a briefing on a new Points to Consider document on Plasmid DNA Vaccines for Preventive Infectious Disease Indications.

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products Advisory Committee

Meeting Date: 7/10/96-7/11/96

Meeting Details:

On July 10, 1996, the committee will review safety and efficacy data pertaining to a diphtheria/tetanus/ acellular pertussis vaccine manufactured by SmithKline Beecham. On July 11, 1996, the committee will review safety and comparative immunogenicity data pertaining to a liquid version of an Haemophilus b conjugate vaccine manufactured by Merck & Co. The committee will also hear a briefing on proposed changes in the polio vaccine recommendations, and a briefing on a research program in the Division of Viral Products.

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products Advisory Committee

Meeting Date: 4/10/96-4/11/96

Meeting Details:

On April 10, 1996, the committee will discuss data issues pertaining to pediatric studies using vaccines for the prevention of Lyme disease. The committee will also review safety and efficacy data pertaining to a Bacille Calmette-Guerin (BCG) vaccine from Connaught Laboratories, Ltd., for the prevention of tuberculosis. On April 11, l996, the committee will: (1) Discuss vaccine safety issues, (2) review a research program in the Division of Viral Products, and (3) hear a briefing on reverse transcriptase in avian cells.

 

       
Location: n/a Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines & Related Biological Products

Meeting Date: 1/29/96-1/31/96

Meeting Details:

On January 29, 1996, the committee will review safety and efficacy data relating to a product licensing application for a rabies vaccine by Behringwerke A. G. and a product licensing application for a combined diphtheria, tetanus, and acellular pertussis (whooping cough) vaccine with infant indication from Connaught Laboratories. On January 30, l996, the committee will discuss the influenza virus vaccine formulation for 1996-1997 and sequential schedules of inactivated polio vaccines and oral polio vaccines. On January 31, l996, the committee will review safety and efficacy data relating to a product licensing application from Merck for an inactivated Hepatitis A vaccine.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products Advisory Committee

Meeting Date: 10/26/95-10/27/95

Meeting Details:

On October 26, 1995, the committee will hear presentations on recent acellular pertussis trials sponsored by the Public Health Service, and on a new strategic plan for the year 2004 developed by the Center for Biologics Evaluation and Research. The committee will also consider whether a single formulation for pneumococcal conjugate vaccines should be adopted for children in the United States. On October 27, l995, the committee will discuss a draft Points to Consider document addressing the evaluation of combination vaccines. Copies of the document will be available at the meeting.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines & Related Biological Products

Meeting Date: 1/30/95-1/30/95

Meeting Details:

The committee will discuss the influenza virus vaccine formulation for 1997-1998. The committee will also hear briefings on a research program in the Division of Bacterial Products and on recent activities in the Center for Biologics Evaluation and Research.

 

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

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines & Related Biological Products

Meeting Date: 11/18/94-11/18/94

Meeting Details:

The committee will hear presentations pertaining to matters previously considered by, pending consideration by, or affecting the advisory process. The committee will also review safety and efficacy data for a live oral polio vaccine. Closed committee deliberations. The committee will review trade secret and/or confidential commercial information relevant to pending investigational new drug applications or product licensing applications.

 

       
Location: November 18, 1994, 8 a.m., Holiday Inn-- Gaithersburg, Ballroom, Two Montgomery Village Ave., Gaithersburg, MD. Related News Links: Not Available
Time: 1:00AM-1:00AM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsVaccines & Related Biological Products

Meeting Date: 8/24/94-8/24/94

Meeting Details:

N/A

 

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

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Upcoming Meetings

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: 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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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Recent Meetings

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

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

Meeting Details:

On May 5, 2016, from 8:00 a.m. to 9:15 a.m., the meeting will be closed to permit discussion and review of trade secret and/or confidential commercial information (5 U.S.C. 552b(c)(4)). During this session, the committees will discuss the drug development program of an investigational abuse-deterrent opioid product. 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    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the DDSRM AdComm and the Anesthetic and Analgesic Drug Products AdComm

Meeting Date: 5/4/16-5/4/16

Meeting Details:

The Food and Drug Administration Amendments Act of 2007 (Public Law 110-85) requires FDA to bring, at least annually, one or more drugs with Risk Evaluation and Mitigation Strategies (REMS) with Elements to Assure Safe Use (ETASU) before its Drug Safety and Risk Management Advisory Committee (DSaRM). On May 3 and 4, 2016, the committees will discuss results from assessments of the extended-release and long-acting (ER/LA) Opioid Analgesics REMS. The Agency will seek the committees’ comments as to whether this REMS with ETASU assures safe use, is not unduly burdensome to patient access to the drugs, and to the extent practicable, minimizes the burden to the healthcare delivery system.

 

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

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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    
Materials:
   
       

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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    
Materials:
   
       

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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    
Materials:
   
       

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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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Past Meetings

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

Live Meetings

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