FDALiveFDALive.com

The World's Leading Source for FDA Broadcasting

Past Meetings

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 OptionsPediatric Advisory Committee

Meeting Date: 4/21/14-4/21/14

.

Meeting Details:

On April 21, 2014, 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). The PAC will meet to discuss Activa Dystonia Therapy, ADVATE (antihemophilic factor (recombinant)), FAMVIR (famciclovir), INTELENCE (etravirine), KEPPRA (levetiracetam), MAXALT and MAXALT MLT (rizatriptan), NATAZIA (estradiol valerate and estradiol valerate/dienogest), PERTZYE (pancrelipase), PERZISTA (darunavir), REYATAZ (atazanavir), SKLICE (ivermectin), TISSEEL (fibrin sealant), TORISEL (temsirolimus), ULTRESA (pancrelipase), Vertical Expandable Prosthetic Titanium Rib (VEPTR), and VIREAD (tenofovir disoproxil fumarate).

 

       
Location: Bethesda Marriott 5151 Pooks Hill Road Bethesda, MD 20814 Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsAnesthetic and Analgesic Drugs AdComm

Meeting Date: 4/22/14-4/22/14

.

Meeting Details:

The committee will discuss the safety and efficacy for new drug application 203077, MOXDUO (morphine sulfate and oxycodone hydrochloride) capsules, QRxPharma Inc., for the proposed indication of management of moderate to severe acute pain where the use of an opioid analgesic is appropriate. This product represents the first drug combination consisting of two immediate-release opioids.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel of the Medical Devices Advisory Committee

Meeting Date: 4/24/14-4/24/14

.

Meeting Details:

On April 24, 2014, the committee will discuss the current knowledge about the safety and effectiveness of aversive conditioning devices that are intended to deliver a noxious electrical stimulus to a patient to modify undesirable behavioral characteristics. FDA is convening this committee to seek clinical and scientific expert opinion on the risks and benefits of certain aversive conditioning devices based on available scientific data and information. The Agency is considering whether to ban aversive conditioning devices that are intended to administer a noxious electrical stimulus to a patient to modify undesirable behavioral characteristics. The meeting will concern only devices classified under 21 CFR 882.5235 (aversive conditioning device, class II) that are not self-administered. Devices which deliver a noxious electrical stimulus automatically are not considered to be self-administered devices. Section 516 of the FD&C Act (21 U.S.C. 360f) sets forth the standard for banning devices. Under that provision, in order to ban a device, FDA must make a finding that a device "presents substantial deception or an unreasonable and substantial risk of illness or injury" based on all available data and information. FDA regulations provide additional details about the procedures and standards for banning a device (21 CFR part 895).

 

       
Location: Holiday Inn - Main Ballroom 2 Montgomery Village Ave. Gaithersburg, MD 20879 Related News Links: Not Available
Time: 8:00AM-6:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsNonprescription Drugs AdComm

Meeting Date: 5/2/14-5/2/14

.

Meeting Details:

The committee will discuss data submitted by MSD Consumer Care, Inc., to support a new drug application (NDA) 204804 for over-the-counter (OTC) marketing of montelukast 10 milligram (mg) tablets (proposed trade name SINGULAIR Allergy). The proposed OTC use is "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: Nasal congestion, runny nose, itchy, watery eyes, sneezing, itching of the nose.” The applicant proposes to label the product for OTC use in adults 18 years and older. Efficacy and safety data, as well as results of consumer studies, will be discussed. The committee will be asked to consider whether the data support an acceptable risk/benefit profile for the nonprescription use of montelukast tablets by OTC consumers.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsRisk Communication AdComm

Meeting Date: 5/5/14-5/6/14

.

Meeting Details:

On May 5-6, 2014, the Committee will meet to discuss methods for identifying the impact and increasing the reach of communications on topics of interest to consumers. The discussion will also address how FDA can evaluate whether its Consumer Updates (http://www.fda.gov/ForConsumers/ConsumerUpdates/default.htm disclaimer icon ) are reaching the targeted population, and whether they are increasing awareness and understanding of the key risk messages. The discussion will also assess whether the communications are having the intended impact on knowledge, behaviors and/or outcomes.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsCirculatory System Devices Panel

Meeting Date: 5/6/14-5/7/14

.

Meeting Details:

On May 6, 2014, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the RESQCPR System sponsored by Advanced Circulatory Systems, Inc. The RESQCPR System is comprised of two devices: the RESQPOD 16.0 Impedance Threshold Device, and the RESQPUMP Active Compression Decompression CPR Device. These devices are used together during manual cardiopulmonary resuscitation (CPR) in an attempt to enhance venous return to the heart and blood flow to vital organs during CPR to ultimately increase survival and neurologic outcome in patients suffering from out of hospital cardiac arrest. Advanced Circulatory Systems, Inc. has proposed the following indications for use: the RESQCPR System is intended for use in the performance of CPR to increase survival with favorable neurologic function in adult patients with non-traumatic cardiac arrest. On May 7, 2014, during session I, the committee will discuss and make recommendations regarding the classification of membrane lung for long-term pulmonary support systems, one of the remaining preamendment Class III devices regulated under the 510(k) pathway. A membrane lung for long-term pulmonary support refers to the oxygenator component of an extracorporeal circuit used during long-term procedures, commonly referred to as extracorporeal membrane oxygenation (ECMO). An ECMO procedure provides assisted extracorporeal circulation and physiologic gas exchange of a patient's blood when an acute (reversible) condition prevents the patient's own body from providing the physiologic gas exchange needed to sustain life. The circuit is comprised of multiple device types, including, but not limited to, an oxygenator, blood pump, cannulae, heat exchanger, tubing, filters, monitors/detectors, and other accessories; the circuit components and configuration (e.g., arteriovenous, veno-venous) may differ based on the needs of the individual patient or the condition being treated. ECMO is currently used for patients with acute reversible respiratory or cardiac failure, unresponsive to optimal ventilation and/or pharmacologic management.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOphthalmic Devices Panel

Meeting Date: 5/13/14-5/13/14

.

Meeting Details:

On May 13, 2014, the committee will discuss and make recommendations regarding the guidance documents for contact lenses and contact lens accessories.

 

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

View Meeting Details / News

Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm

Meeting Date: 4/1/14-4/1/14

Meeting Details:

The committee will discuss new drug application (NDA) 22-472, proposed trade name AFREZZA (TECHNOSPHERE Insulin Inhalation System), 3 unit and 6 unit cartridges for oral inhalation, manufactured by MannKind Corporation. The proposed indication (use) for this application is to improve glycemic control in adult patients with type 1 or type 2 diabetes mellitus.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsAnti-Infective Drugs Advisory Committee

Meeting Date: 3/31/14-3/31/14

Meeting Details:

During the morning session, the committee will discuss new drug applications (NDAs) 205-435 and 205-436, tedizolid phosphate tablets and tedizolid phosphate injection, submitted by Trius Therapeutics, respectively, for the proposed indication of treatment of acute bacterial skin and skin structure infections. During the afternoon session, the committee will discuss NDA 021-883, dalbavancin hydrochloride for intravenous injection, submitted by Durata Therapeutics International B.V., for the proposed indication of treatment of acute bacterial skin and skin structure infections.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs AdComm

Meeting Date: 3/27/14-3/27/14

Meeting Details:

The committee will discuss biologics license application 125468, serelaxin injection, submitted by Novartis, as a treatment to improve the symptoms of acute heart failure through reduction of the rate of worsening of heart failure.

 

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

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsMolecular and Clinical Genetics Panel

Meeting Date: 3/26/14-3/27/14

Meeting Details:

On March 26, 2014, the committee will discuss, make recommendations and vote on information related to the premarket approval application sponsored by Epigenomics, Inc. for the Epi proColon. The Epi proColon test is a qualitative in vitro diagnostic method for the detection of methylated Septin 9 DNA in plasma derived from patient whole blood specimens. Methylation of the target Septin 9 DNA sequence has been associated with the occurrence of colorectal cancer (CRC). The test is indicated to screen patients for CRC who are defined as average risk for CRC by current screening guidelines. The Epi proColon test is not intended to replace colorectal screening by colonoscopy. Patients with a positive Epi proColon test result should be referred for diagnostic colonoscopy. The Epi proColon test results are intended to be used in conjunction with the physician's assessment of history, other risk factors, and professional guidelines. On March 27, 2014, the committee will discuss, make recommendations and vote on information related to the premarket approval application for the Cologuard device, sponsored by Exact Sciences. Cologuard is an in vitro diagnostic device designed to analyze patients' stool for detection of hemoglobin, multiple DNA methylation and mutational markers, and the total amount of human DNA. Cologuard is intended for use as an adjunctive screening test for the detection of colorectal neoplasia associated DNA markers and for the presence of occult hemoglobin in human stool. A positive result may indicate the presence of colorectal cancer or premalignant colorectal neoplasia. Cologuard is not intended as a replacement for colonoscopy. Cologuard is intended to be used in conjunction with colonoscopy and other test methods in accordance with recognized screening guidelines.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-5:00PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsGastroenterology and Urology Devices Panel

Meeting Date: 3/20/14-3/20/14

Meeting Details:

On March 20, 2014, the committee will discuss, make recommendations, and vote on information regarding the humanitarian device exemption (HDE) application for the XVIVO Perfusion System (XPSTM) sponsored by XVIVO Perfusion, Inc. The proposed Indication for Use for the XVIVO Perfusion System, as stated in the HDE, is as follows: The XPSTM is intended to be used with STEEN Solution for flushing and temporary continuous normothermic machine perfusion of initially unacceptable excised donor lungs during which time the function of the lungs can be reassessed for transplantation.

 

       
Location: Holiday Inn, GBurg Related News Links: Not Available
Time: 8:00AM-5:00PM    
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.