Vaccines and Related Biological Products Advisory Committee
September 25, 2008 Meeting
Date and Time:
The meeting will be held on September 25, 2008 from 8:30 a.m. to approximately 4 p.m.
Location:
Crowne Plaza Hotel, 8777 Georgia Ave., Silver Spring, MD 20910
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:
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.
Oral Presentations:
Oral presentations from the public will be scheduled between approximately 2 p.m. and 3 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before September 8, 2008.