Vaccines and Related Biological Products Advisory Committee
March 7-9, 2001 Meeting
Date and Time
The meeting will be held on March 7, 2001, 8:00 a.m. to 6:30 p.m.; March 8, 2001, 8:00 a.m. to 6:30 p.m.; and on March 9, 2001, 8:00 a.m. to 12:30 p.m.
Location
Holiday Inn, Versailles Ballrooms I and II, 8120 Wisconsin Avenue, Bethesda, MD, 20814, 301-652-2000.
Contact Person
Nancy T. Cherry or Denise H. Royster, 301-827-0314, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 12391. Please call the Information Line for up-to-date information on this meeting.
Agenda
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.
Oral Presentations
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.
Closed Committee Deliberations
On March 7, 2001, from 8:00 to 9:00 am; and on March 8, 2001, from 8:00 to 10:00 a.m., the meeting will be closed to permit discussion and review of trade secret and/or confidential information. (5 U.S.C. 552b(c)(4)). This portion of the meeting will be closed to permit discussion of pending investigational new drug applications. On March 9, 2001, from 11:00 a.m. to 12:30 p.m. the meeting will be closed to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy. (5 U.S.C. 552b(c)(6)). The meeting will be closed to discuss personal information concerning individuals associated with the research programs.
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