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Food and Drug Administration

Vaccines and Related Biological Products Advisory Committee

September 25, 2008


Topic 1

Office of Vaccines Research and Review; Response to the 2006 Office Site Visit Report, Erik Henchal, Ph.D., FDA (htm)

Topic 2

Use of Madin-Darby Canine Kidney (MDCK) Cells for Manufacture of Live-Attenuated Influenza Virus Vaccine, CDR Timothy Nelle, Ph.D., FDA  (htm)

Live, Attenuated Influenza Vaccine Manufactured in MDCK Cells, George Kemble, Ph.D., MedImmune  (pdf)

Use of MDCK Cells for the Production of Live Attenuated Influenza Vaccines: Characteristics and Issues Associated With Their Tumorigenic Phenotype, Keith Peden, Ph.D., FDA  (htm)

Issues Associated With Residual Cell-Substrate DNA: An Update, Keith Peden, Ph.D., FDA  (htm)

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