FDALiveFDALive.com

The World's Leading Source for FDA Broadcasting

Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products Advisory Committee

Meeting Date: 5/11/16-5/11/16

Meeting Details:

On May 11, 2016, the committee will meet by teleconference. In open session, the committee will hear updates of the research program in the Laboratory of Bacterial Polysaccharides, Division of Bacterial, Parasitic, and Allergenic Products, Center for Biologics Evaluation and Research, FDA.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 1:00PM-4:30PM    
Materials:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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    
Materials:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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    
Materials:
   
       

View Meeting Details / News

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    
Materials:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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    
Materials:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

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:
   
       

View Meeting Details / News

Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPharmacy Compounding AdComm

Meeting Date: 5/8/17-5/9/17

.

Meeting Details:

The committee will receive updates on certain issues to follow up on discussions from previous meetings, including quality standards and conditions at certain compounding facilities. In addition, the committee intends to discuss six bulk drug substances nominated for inclusion on the section 503A Bulks List. FDA will discuss the following nominated bulk drug substances: nicotinamide adenine dinucleotide, nicotinamide adenine dinucleotide disodium reduced, nettle (Urtica dioica) whole plant, ubiquinol, vanadyl sulfate, and artemisinin. The chart below describes which use(s) FDA reviewed for each of the six bulk drug substances being discussed at this advisory committee meeting. The nominators of these substances will be invited to make a short presentation supporting the nomination.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:30AM-4:30PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMedical Imaging Drugs AdComm

Meeting Date: 5/10/17-5/10/17

.

Meeting Details:

The committee will discuss new drug application (NDA) 208-630 for 5-Aminolevulinic Acid Hydrochloride [5-ALA HCl], Powder, for oral solution, submitted by NX Development Corp., for the proposed indication as an imaging agent to facilitate the real time detection and visualization of malignant tissue during glioma surgery.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-4:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel of the Medical Devices AdComm

Meeting Date: 5/17/17-5/17/17

.

Meeting Details:

On May 17, 2017, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for the TRANSMEDICS ORGAN CARE SYSTEM (OCS)--Lung System, by TransMedics, Inc. The proposed Indication for Use, as stated in the PMA, is as follows: The TRANSMEDICS ORGAN CARE SYSTEM (OCS) Lung System is a portable organ perfusion, ventilation, and monitoring medical device intended to preserve donor lungs in a near physiologic, ventilated, and perfused state for transplantation.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsVaccines and Related Biological Products AdComm

Meeting Date: 5/17/17-5/17/17

.

Meeting Details:

On May 17, 2017, the VRBPAC will meet in an open session to discuss considerations for evaluation of Respiratory Syncytial Virus vaccine candidates in seronegative infants.

 

       
Location: FDA White Oak Related News Links: Not Available
Time: 8:30AM-4:45PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsJoint Meeting of the Pediatric AdComm and the Pediatric Ethics Subcommittee

Meeting Date: 5/18/17-5/18/17

.

Meeting Details:

On May 18, 2017, the PAC and the PES will meet to discuss a referral by an Institutional Review Board (IRB) of a clinical investigation that involves children and FDA regulated products. The clinical investigation is entitled “A Double-Blind, Placebo-Controlled, Multi-Center Study with an Open-Label Extension to Evaluate the Efficacy and Safety of SRP 4045 and SRP-4053 in Patients with Duchenne Muscular Dystrophy.” Comments about the upcoming joint meeting should be submitted to Docket No. FDA 2017-N-1780.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs AdComm

Meeting Date: 5/24/17-5/25/17

.

Meeting Details:

On May 24th during the morning session, the committee will discuss new drug application (NDA) 208051, for neratinib maleate, an application submitted by Puma Biotechnology. The proposed indication (use) for this product is as a single agent for the extended adjuvant treatment of adult patients with early-stage HER2-overexpressed/amplified breast cancer who have received prior adjuvant traustuzumab-based therapy. During the afternoon session, the committee will discuss NDA 208587, for L-glutamine powder (oral solution), submitted by Emmaus Medical, Inc. The proposed indication (use) for this product is for the treatment of sickle cell disease. On May 25th the committee will discuss biologics license application (BLA) 125545, for a proposed biosimilar to Amgen Inc.'s Epogen/Procrit (epoetin alfa), submitted by Hospira Inc., a Pfizer company. The proposed indications/uses for this product are: (1) For the treatment of anemia due to chronic kidney disease, including patients on dialysis and not on dialysis, to decrease the need for red blood cell (RBC) transfusion; (2) for the treatment of anemia due to zidovudine administered at = 4,200 mg/week in HIV-infected patients with endogenous serum erythropoietin levels of = 500 m units/mL; (3) for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppresive chemotherapy, and upon initiation, there is a minimum of 2 additional months of planned chemotherapy; and (4) to reduce the need for allogeneic RBC transfusions among patients with perioperative hemoglobin > 10 to <13 g/dL who are at high risk for perioperative blood loss from elective, noncardiac, and nonvascular surgery.

 

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

View Meeting Details / News

Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsAntimicrobial Drugs Advisory Committee

Meeting Date: 4/13/17-4/13/17

Meeting Details:

The committee will discuss the development of antibacterial drugs that treat a single species of bacteria when the target species infrequently causes infections; examples of such drugs include those that are only active against Pseudomonas aeruginosa or Acinetobacter baumannii.

 

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

View Meeting Details / News

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

Meeting Date: 4/5/17-4/5/17

Meeting Details:

The committees will discuss new drug application (NDA) 209777, for oxycodone hydrochloride immediate-release oral tablets, submitted by Inspirion Delivery Sciences, LLC., with the proposed indication of management of moderate to severe pain where the use of an opioid analgesic is appropriate. The product has been formulated with properties intended to deter abuse, and the applicant has submitted data to support these abuse-deterrent properties for this product. The committees will be asked to discuss the overall risk-benefit profile of the product, and whether the applicant has demonstrated abuse-deterrent properties for their product that would support labeling.

 

       
Location: Tommy Douglas Conference Center Related News Links: Not Available
Time: 9:15AM-5:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsJoint Meeting Nonprescription AdComm & DSRM AdComm

Meeting Date: 4/4/17-4/4/17

Meeting Details:

The committees will discuss safety issues associated with over-the-counter analgesic combination products used for upset stomach (i.e., heartburn, nausea, fullness, belching, gas, acid indigestion, and/or sour stomach) and hangover indications under the Internal Analgesic and Antacid monographs in 21 CFR part 343 and 21 CFR part 331, respectively. The committees will also be asked to discuss the hangover indication under the Overindulgence, Internal Analgesic, and Stimulant monographs in 21 CFR part 357 subpart J, 21 CFR part 343, and 21 CFR part 340, respectively.

 

       
Location: Tommy Douglas Conference Center Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsBlood Products AdComm

Meeting Date: 4/4/17-4/5/17

Meeting Details:

On April 4, 2017, in open session, the Committee will discuss Recombinant Human Coagulation Factor IX, GlycoPEGylated. In the afternoon, in open session, the Committee will hear an update presentation on a summary of responses to Docket FDA-2016-N-1502: Blood Donor Deferral Policy for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products. On April 5, 2017, in open session, the committee will hear overview presentations on the research programs in the Laboratory of Emerging Pathogens in the Division of Emerging Transfusion-Transmitted Diseases, Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA. At the conclusion of the open session, the meeting will be closed to permit discussion where disclosure would constitute an unwarranted invasion of personal privacy in accordance with 5 U.S.C 552b(c)(6). During the closed session, the Committee will discuss the research progress made by staff involved in the intramural research programs and make recommendations regarding their personnel actions and staffing decisions.

 

       
Location: Tommy Douglas Conference Center Related News Links: Not Available
Time: 8:30AM-3:45PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Advisory Committee

Meeting Date: 3/29/17-3/29/17

Meeting Details:

During the morning session of March 29, 2017, the committee will discuss biologics license application (BLA) 761064, rituximab/hyaluronidase injection for subcutaneous use, submitted by Genentech, Inc. The proposed indications (uses) for this product are for: (1) The treatment of patients with relapsed or refractory, follicular lymphoma as a single agent; (2) previously untreated follicular lymphoma in combination with first line chemotherapy and, in patients achieving a complete or partial response to rituximab/hyaluronidase for subcutaneous injection in combination with chemotherapy, as single-agent maintenance therapy; (3) nonprogressing (including stable disease), follicular lymphoma as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy; (4) the treatment of patients with previously untreated diffuse large B-cell lymphoma (DLBCL) in combination with cyclophosphamide, doxorubicin, vincristine, prednisolone (CHOP) or other anthracycline based chemotherapy regimens; and (5) in combination with fludarabine and cyclophosphamide (FC), for the treatment of patients with previously untreated and previously treated chronic lymphocytic leukemia (CLL). During the afternoon session, the committee will discuss new drug application (NDA) 209099, for binimetinib, submitted by Array BioPharma Inc. The proposed indication (use) for this product is for the treatment of patients with unresectable or metastatic melanoma, with NRAS Q61 mutation as detected by an FDA-approved test, who have received prior treatment with checkpoint inhibitor therapy.

 

       
Location: Sheraton Related News Links: Not Available
Time: 8:00AM-12:30PM    
Materials:
   
       

View Meeting Details / News

Past Meetings

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

Live Meetings

There are no Live Broadcasts available at this time.