Recently Updated Advisory Committee Materials

Recently Updated Advisory Committee Materials

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Recently Updated Advisory Committee Materials

 

Posted on May 07, 2012

Pediatric Advisory Committee

• 2012 Meeting Materials, Pediatric Advisory Committee to the Food and Drug Administration
• Meeting Roster for the May 7 - 8, 2012 Meeting of the Pediatric Advisory Committee  (PDF - 132KB)

Peripheral and Central Nervous System Drugs Advisory Committee

• Curriculum Vitae: Samuel A. Frank, M.D.  (PDF - 447KB)
• Curriculum Vitae: Jeffrey A. Cohen, M.D.  (PDF - 97KB)

Pharmaceutical Science and Clinical Pharmacology Advisory Committee

• Transcript for the March 14, 2012 Meeting of the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology  (PDF - 441KB)
• 2012 Meeting Materials, Pharmaceutical Science and Clinical Pharmacology Advisory Committee

Arthritis Advisory Committee

• Draft Meeting Roster for the May 9, 2012 Meeting of the Arthritis Advisory Committee  (PDF - 50KB)
• Draft Questions for the May 9, 2012 Meeting of the Arthritis Advisory Committee  (PDF - 22KB)
• Webcast Information for the May 9, 2012 Meeting of the Arthritis Drugs Advisory Committee  (PDF - 26KB)
• FDA Briefing Information for the May 9, 2012 Meeting of the Arthritis Advisory Committee (PDF – 10.30MB)  (PDF - 10.1MB)
• Briefing Information for the May 9, 2012 Meeting of the Arthritis Drugs Advisory Committee
• Errata to the FDA Briefing Information for the May 9, 2012 Meeting of the Arthritis Advisory Committee (PDF – 52KB)  (PDF - 52KB)
• Draft Agenda for the May 9, 2012 Meeting of the Arthritis Advisory Committee  (PDF - 40KB)
• Committee Roster for the May 9, 2012 Meeting of the Arthritis Advisory Committee  (PDF - 27KB)
• Pfizer Briefing Information for the May 9, 2012 Meeting of the Arthritis Advisory Committee (PDF – 4.70MB)  (PDF - 4.6MB)

Pediatric Advisory Committee

• Presentation Slides for the May 7-8, 2012 Meeting of the Pediatric Advisory Committee
• Review of Post-market Reports in the Adverse Event Reporting System (AERS) Database Associated with Oseltamivir use in Pediatric (0 to 16 years) Patients  (PDF - 115KB)
• Salute to Pediatric Safety  (PDF - 310KB)
• Pediatric Focused Safety Review: MultiHance  (PDF - 135KB)
• Pre-licensure Safety Data: GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]  (PDF - 59KB)
• Surveillance for adverse events associated with oseltamivir in a healthcare claims database  (PDF - 213KB)
• Gardasil Post‐licensure Pediatric Safety and Adverse Event Review  (PDF - 202KB)
• Tamiflu® (oseltamivir) Background Information and Drug Utilization Patterns  (PDF - 83KB)
• Post-marketing Monitoring of Vaccine Safety May 2012  (PDF - 181KB)
• Pediatric Focused Safety Review: Differin  (PDF - 184KB)
• Tamiflu® (Oseltamivir) Safety Assessment, Vaccine Safety Datalink Project, 2007‐2010  (PDF - 522KB)
• Post-licensure Pediatric Safety and Utilization Review: Menveo  (PDF - 135KB)
• Roster of the Pediatrics Advisory Committee to the Food and Drug Administration May 7-8, 2012  (PDF - 97KB)
• Pre-licensure Safety Data: MENVEO Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine  (PDF - 88KB)
• Pediatric Focused Safety Review: Dulera  (PDF - 229KB)
• Pediatric Focused Safety Review: Viread May 2012  (PDF - 241KB)
• Preliminary Data from a Pilot Study of Proton Pump Inhibitor Use in Infants <1 year in Intensive Care Units>  (PDF - 209KB)
• Pediatric Focused Safety Review: Nasonex  (PDF - 177KB)