FDA Presentations

• November 16, 2011: Vaccines and Related Biological Products Advisory Committee Meeting: Update on Surveillance for Guillain-Barré Syndrome After Vaccination with Pandemic Influenza A/H1N1 2009-Containing Vaccines, 2009–2011 (PPT - 357KB)
  Sukhminder K. Sandhu, PhD, MPH, MS, LCDR, USPHS
• November 16, 2011: Vaccines and Related Biological Products Advisory Committee Meeting: Office of Vaccines Research and Review (PPT - 666KB)
  Konstantin Chumakov, PhD
• November 16, 2011: Vaccines and Related Biological Products Advisory Committee Meeting: Site Visit for the Laboratory of Method Development (PPT - 36KB)
  Jerry P Weir, Ph.D.
• November 16, 2011: Vaccines and Related Biological Products Advisory Committee Meeting: Prevnar 13 for Adult Use Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) (PPT - 186KB)
  Nicolette deVore, Ph.D.
• November 16, 2011: Vaccines and Related Biological Products Advisory Committee Meeting: Prevnar 13 for Adult Use (Age >50 Years) (Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) (PPT - 529KB)
  Rosemary Tiernan, MD, MPH
• November 16, 2011: Vaccines and Related Biological Products Advisory Committee Meeting: CBER Clinical Review of Immunogenicity Data Supporting the Effectiveness of Prevnar 13 for the Prevention of Pneumococcal Disease in Adults Aged ≥ 50 Years (PPT - 444KB)
  Tina Khoie, M.D., M.P.H
• November 16, 2011: Vaccines and Related Biological Products Advisory Committee Meeting: Applying Regulatory Science to Advance Development of Innovative, Safe and Effective Biologic Products (PPT - 1023KB)
  Carolyn A. Wilson, Ph.D.
• November 16, 2011: Vaccines and Related Biological Products Advisory Committee Meeting: Prevnar 13 for Adult Use Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) (PPT - 227KB)
  Mustafa Akkoyunlu, M.D. Ph.D.

Sponsor Presentations

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• November 16, 2011: Vaccines and Related Biological Products Advisory Committee Meeting: Prevention of Pneumococcal Disease in Adults ≥50 Years of Age (PDF - 595KB)
  William C. Gruber, MD