Recently Updated Advisory Committee Materials

 

Posted on September 22, 2011

Advisory Committee Calendar

• November 17-18, 2011: Risk Communication Advisory Committee Meeting Announcement¹
• September 22-23, 2011: Pediatric Advisory Committee Meeting Announcement²

Pediatric Advisory Committee

• Slides for the September 22 - 23 Meeting of the Pediatric Advisory Committee³
• Zidovudine Medication Errors⁴  (PDF - 30KB)
• Afluria Influenza Virus Vaccine: Pre-Licensure Safety Data⁵  (PDF - 122KB)
• Pediatric Focused Safety Review: Topamax (topiramate)⁶  (PDF - 228KB)
• Melody TPV: Questions for the Committee⁷  (PDF - 19KB)
• Pediatric Focused Safety Review: Levaquin⁸  (PDF - 128KB)
• Pediatric Safety and Utilization Review: FLUARIX⁹  (PDF - 92KB)
• Informational Update: Kaletra Oral Solution Toxicity in Neonates—Lopinavir, Ethanol and/or Propylene Glycol?¹⁰  (PDF - 139KB)
• Atypical Antipsychotics and Safety Reporting to the PAC¹¹  (PDF - 26KB)
• FDA-AHRQ Collaboration on the Comparative Safety of Antipsychotics in Adolescents and Children¹²  (PDF - 31KB)
• Pediatric Safety and Utilization Review: AFLURIA¹³  (PDF - 208KB)
• Pediatric Focused Safety Review: Retrovir (zidovudine)¹⁴  (PDF - 224KB)
• Pediatric Focused Safety Review: Abilify (aripiprazole)¹⁵  (PDF - 111KB)
• FLUARIX Influenza Virus Vaccine: Review of Pre-Licensure Safety Data¹⁶  (PDF - 74KB)
• Second Generation Antipsychotics and Risk of Type 2 Diabetes in Publicly Insured Children and Adolescents¹⁷  (PDF - 458KB)
• Why do we need another process and what is a "PAC Directed Abbreviated Review"¹⁸  (PDF - 30KB)
• Abbreviated and Expanded-Abbreviated Presentations¹⁹  (PDF - 234KB)
• Medtronic Melody Transcatheter Pulmonary Valve (TPV) & Ensemble Transcatheter Valve Delivery System²⁰  (PDF - 294KB)

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Recently Updated Advisory Committee Materials