Vaccines and Related Biological Products Advisory Committee

September 25, 2008

Briefing Information

Topic 1

FDA

Disclaimer

Portions of this documernt(s) have been determined to be exempt from disclosure under the Freedom of Information Act (the FOIA) (5 U.S.C. §5520. these redacted portions will appear as white space on the screen or on the printed page.

FDA Briefing Document, Office of Vaccines Research and Review (OVRR) Response to January 25, 2007 VRBPAC Approved Office Site Visit Report (htm)

FDA Briefing Document, OVRR Office Site Visit Report, May 19, 2006 (htm)

Topic 2

FDA Briefing Document, Background Summary for the September 25, 2008, VRBPAC Meeting; Use of MDCK Cells for Manufacture of Live Attenuated Influenza Vaccines (pdf)

FDA Briefing Document, Background Summary for the November 16, 2005, VRBPAC Meeting: Use of MDCK Cells for Manufacture of Inactivated Influenza Vaccines. http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4188b1.htm

Sponsor

Disclaimer

The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements FDA has not made a final determination about the safety or effectiveness of the product described in this document.

MedImmune Briefing Document, Use of Madin Darby Canine Kidney Cells for the Manufacture of Live, Attenuated Influenza Vaccines (pdf)