November 18-19, 2009: Vaccines and Related Biological Products Advisory Committee Briefing Documents

November 18-19, 2009: Vaccines and Related Biological Products Advisory Committee Briefing Documents

-November 18, 2009: Vaccines and Related Biological Products Advisory Committee Meeting: Topic 1

* November 18, 2009: Vaccines and Related Biological Products Advisory Committee Meeting Transcript (PDF - 484KB / 284 páginas)
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/UCM197910.pdf


** November 18, 2009: Vaccines and Related Biological Products Advisory Committee Meeting: Prevnar 13 Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein] (PPT - 125KB)
Julienne Vaillancourt, R.Ph., M.P.H.
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/UCM195723.ppt


*** November 18, 2009: Vaccines and Related Biological Products Advisory Committee Meeting: Epidemiology of Pneumococcal Disease in the U.S. in the Conjugate Vaccine Era (PPT - 316KB)
Matthew R. Moore, MD, MPH CDR, USPHS
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/UCM195728.ppt


**** November 18, 2009: Vaccines and Related Biological Products Advisory Committee Meeting: Primary Immunogenicity Endpoints for New Infant Pneumococcal Conjugate Vaccines (PPT - 199KB)
Lucia H. Lee, M.D.
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/UCM195725.ppt


***** November 18, 2009: Vaccines and Related Biological Products Advisory Committee Meeting: Prevnar 13 Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein] (PPT - 978KB)
Tina Khoie, M.D., M.P.H
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/UCM198063.ppt


****** November 18, 2009: Vaccines and Related Biological Products Advisory Committee Meeting: Pneumococcal 13-valent Conjugate Vaccine Post Licensure Pharmacovigilance and Vaccine Effectiveness Plans (PPT - 150KB)
Robert Wise, MD, MPH
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/UCM195737.ppt


******* November 18, 2009: Vaccines and Related Biological Products Advisory Committee Meeting: Questions for the Committee (PPT - 109KB)
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/UCM195739.ppt


November 18, 2009: Vaccines and Related Biological Products Advisory Committee Meeting: Topic 1

November 18, 2009: Vaccines and Related Biological Products Advisory Committee Meeting: Prevnar 13 Pneumococcal 13-valent Conjugate Vaccine (Diptheria CRM197 Protein) (PPT - 18267KB)
Wyeth / demora unos minutos en bajar:
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/UCM198069.ppt



Others topics (please open here):
abrir aquí:
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/ucm190714.htm

November 18, 2009: Vaccines and Related Biological Products Advisory Committee Meeting: Topic 2
November 18, 2009: Vaccines and Related Biological Products Advisory Committee Meeting: Safety Monitoring of 2009 Pandemic H1N1 Influenza Vaccines (PPT - 716KB)
Hector Izurieta
November 18, 2009: Vaccines and Related Biological Products Advisory Committee Meeting: Monitoring the Safety of Influenza A (H1N1) 2009 Monovaler Vaccines (PPT - 2435KB)
Claudia Vellozzi, MD, MPH

--November 19, 2009: Vaccines and Related Biological Products Advisory Committee Meeting: Day 1Topic 2 Continued

November 19, 2009: Vaccines and Related Biological Products Advisory Committee Transcript (PDF - 299KB)
November 19, 2009: Vaccines and Related Biological Products Advisory Committee Meeting: Enhanced Surveillance of Novel H1N1 Vaccines Among Military Personnel (PPT - 1045KB)
LTC Patrick Garman, PharmD, PhD
November 19, 2009: Vaccines and Related Biological Products Advisory Committee Meeting: The PRISM (Post-Licensure Rapid Immunization Safety Monitoring) System for H1N1 Vaccine (PPT - 227KB)
Richard Platt, MD, MS

--November 19, 2009: Vaccines and Related Biological Products Advisory Committee Meeting: Day 2Topic 3

November 19, 2009: Vaccines and Related Biological Products Advisory Committee Meeting: FluBlok®: Influenza Vaccine, Recombinant Hemagglutinin (PPT - 120KB)
Rakesh Pandey, Ph.D.
November 19, 2009: Vaccines and Related Biological Products Advisory Committee Meeting: Influenza Vaccine, Recombinant Hemagglutinin FluBlok Protein Sciences Corporation (PPT - 7877KB)
Cynthia Nolletti, MD
November 19, 2009: Vaccines and Related Biological Products Advisory Committee Meeting: Influenza Vaccine, Recombinant Hemagglutinin FluBlok Protein Sciences Corporation (PPT - 2168KB)
Cynthia Nolletti, MD
November 19, 2009: Vaccines and Related Biological Products Advisory Committee Meeting: Advax Enhances Response to Pandemic Avian Influenza Vaccine (PPT - 253KB)
Nickolai Petrovsky

--November 19, 2009: Vaccines and Related Biological Products Advisory Committee Meeting: Day 2Persons with disabilities having problems accessing the PowerPoint file may call 301-827-0314 for assistance.

November 19, 2009: Vaccines and Related Biological Products Advisory Committee Meeting: FluBlok® Protein Sciences Corporation Presentation (PPT - 4639KB)
Protein Sciences

abrir aquí:
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/ucm190714.htm