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Food and Drug Administration

Vaccines and Related Biological Products Advisory Committee

February 27, 2007

Slides

Topic 1: FDA Introduction - Safety and Effectiveness of an H5N1 Inactivated Influenza Vaccine, Norman Baylor, Ph.D. (ppt) (htm)

Topic 1: Sanofi Pasteur Introduction, Kenneth Guito, MBA (ppt) (htm)

Topic 1: Overview of HHS Procurement of Sanofi Pasteur's H5N1 Inactivated Influenza Vaccine, Robin Robinson, Ph.D. (ppt) (htm)

Topic 1: Introduction to NIH's Clinical Study, Linda Lambert, Ph.D./NIH Presentation of H5N1 Study Results, John Treanor, M.D. (ppt) (htm)

Topic 1: FDA Presentation of Immunogenicity and Safety Data, Andrea James, M.D. (ppt) (htm)

Topic 1: CDC- Post Marketing Collection of Effectiveness Data, David K. Shay, M.D. (ppt) (htm)

Topic 1: Sanofi Pasteur Presentation of Pharmacovigilence Plan, Patrick Caubel, M.D., Ph.D. (ppt) (htm)

Topic 1: FDA Comments on Sanofi Pasteur Pharmacovigilence Plan/Post Marketing Safety Monitoring During an Influenza Pandemic, Robert Ball, M.D., M.P.H., Sc.M. (ppt) (htm)

Topic2: Introduction – Clinical Development of Influenza Vaccines for Pre-Pandemic Uses, Jesse Goodman, M.D., M.P.H. (ppt) (htm)

Topic 2: Scientific Data Needed to Support Pre-Pandemic Uses, Joseph Toerner, M.D., M.P.H. (ppt) (htm)

Topic 2: Boosting Study Results, John Treanor, M.D. (ppt) (htm)

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