Vaccines and Related Biological Products Advisory Committee
February 20 & 21, 2008 Meeting
Date and Time:
The meeting will be held on February 20, 2008 from 8:30 a.m. to approximately 4 p.m. and on February 21, 2008 from 8:30 a.m. to approximately 4:30 p.m.
Location:
Hilton Hotel DC North/Gaithersburg, 620 Perry Prkwy, Gaithersburg, MD 20877.
Contact Persons:
Christine Walsh or Denise Royster, Center for Biologics Evaluation and Research (HFM-71), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-0314, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512391. Please call the Information Line for up-to-date information on this meeting.
Agenda:
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.
Oral Presentations:
Oral presentations from the public will be scheduled between approximately 1:00 p.m. and 1:30 p.m. on February 20, 2008 and approximately 11:20 a.m. and 11:50 a.m. and 2:45 p.m. and 3:15 p.m. on February 21, 2008. Those desiring to make formal oral presentations should notify the contact person before February 6, 2008.