Food and Drug Administration

Vaccines and Related Biological Products Advisory Committee

November 16, 2005


FDA Draft Slides

Use of MDCK Cells for Manufacture of Inactivated Influenza Vaccines: Introduction, Philip Krause, MD (HTM) (PPT)

Regulatory Implications of Neoplastic Cell Substrate Tumorigenicity, Andrew Lewis, Jr., MD (HTM) (PPT)

Adventitious Agent Testing of Novel Cell Substrates for Vaccine Manufacture, Arifa Khan, PhD (HTM) (PPT)

Issues Associated Wtih Residual Cell-Substrate DNA, Keith Peden (HTM) (PPT)