Vaccines and Related Biological Products Advisory Committee
July 26-27, 2001 Meeting
Date and Time
The meeting will be held on July 26, 2001, 8:30 a.m. to 5:30 p.m., and on July 27, 2001, 8:30 a.m. to 3:30 p.m.
Location
Holiday Inn, Grand Ballroom, 2 Montgomery Village Avenue, Gaithersburg, MD, 301-948-8900.
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 July 26, 2001, the committee will hear presentations on the available safety and efficacy data for Aviron Inc.'s cold adapted, live attenuated, trivalent influenza virus vaccine (FluMistâ). On July 27, 2001, the committee will discuss the available data and the proposed indications for FluMistâ.
Oral Presentations
On July 27, 2001 between approximately 9:00 and 10:15 a.m. oral presentations from the public will be scheduled. Those desiring to make formal presentations should notify the contact person before July 8, 2001.
Closed Committee Deliberations
On July 26, 2001, from 8:30 to 10:15 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)).
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