Agenda

• July 23, 2009: Vaccines and Related Biological Products Advisory Committee Meeting Agenda (PDF - 19KB) 
• July 23, 2009: Vaccines and Related Biological Products Advisory Committee Meeting Discussion Items 

FDA, CDC, NIH and DHHS Presentations

• July 23, 2009: Vaccines and Related Biological Products Advisory Committee Meeting Presentation: FDA Regulatory Pathway to Facilitate the Licensure and Availability of Pandemic (H1N1) 2009 Influenza Virus Vaccines (PPT - 475KB) 
  Norman W. Baylor, Ph.D., FDA
• July 23, 2009: Vaccines and Related Biological Products Advisory Committee Meeting Presentation: Novel Influenza A (H1N1) Epidemiology Update (PPT - 2393KB) 
  Anthony Fiore, M.D., MPH, CDC
• July 23, 2009: Vaccines and Related Biological Products Advisory Committee Meeting Presentation: Pandemic Influenza A (H1N1) Virology Update (PPT - 2202KB) 
  Nancy Cox, Ph.D., CDC
• July 23, 2009: Vaccines and Related Biological Products Advisory Committee Meeting Presentation: Plans to Assess the Effectiveness of Seasonal and Pandemic Influenza Vaccines during 2009-10 (PPT - 143KB) 
  Anthony Fiore, M.D., MPH, CDC
• July 23, 2009: Vaccines and Related Biological Products Advisory Committee Meeting Presentation: Pandemic (H1N1) 2009 Influenza Vaccine Manufacturing Considerations (PPT - 113KB) 
  Jerry Weir, Ph.D., FDA
• July 23, 2009: Vaccines and Related Biological Products Advisory Committee Meeting Presentation: CBER Regulatory Approaches & Activities to Support Licensure of Pandemic (H1N1) 2009 Vaccine (PPT - 118KB) 
  Wellington Sun, M.D., FDA
• July 23, 2009: Vaccines and Related Biological Products Advisory Committee Meeting Presentation: Overview of Clinical Studies by NIAID/NIH (PPT - 841KB) 
  Linda C. Lambert, Ph.D., NIH
• July 23, 2009: Vaccines and Related Biological Products Advisory Committee Meeting Presentation: H1N1 Vaccines; Overview of DHHS Procurement (PPT - 1564KB) 
  Robin Robinson, Ph.D., DHHS
• July 23, 2009: Vaccines and Related Biological Products Advisory Committee Meeting Presentation: Preparedness to Monitor Safety of the Pandemic (H1N1) 2009 Vaccines (PPT - 96KB) 
  Hector S. Izurieta, M.D., MPH, FDA

Other Presentations

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• July 23, 2009: Vaccines and Related Biological Products Advisory Committee: Novartis Vaccines - Influenza A H1N1v Vaccine Development (PPT - 2229KB) 
• July 23, 2009: Vaccines and Related Biological Products Advisory Committee Meeting: Sanofi Pasteur - H1N1 (PPT - 175KB) 
• July 23, 2009: Vaccines and Related Biological Products Advisory Committee Meeting: CSL Ltd. - 2009 Influenza A (H1N1) Vaccine Development Plans (PPT - 9860KB) 
• July 23, 2009: Vaccines and Related Biological Products Advisory Committee Meeting: MedImmune -Influenza A (H1N1) Vaccine (PPT - 603KB) 
• July 23, 2009: Vaccines and Related Biological Products Advisory Committee Meeting: GlaxoSmithKline Biologicals - Development of an Adjuvanted H1N1 Pandemic Vaccine for the United States (PPT - 1989KB)