Presentations

• Atypical Antipsychotics and Safety Reporting to the PAC (PDF - 50KB)
• FDA-AHRQ Collaboration on the Comparative Safety of Antipsychotics in Adolescents and Children (PDF - 31KB)
• Second Generation Antipsychotics and Risk of Type 2 Diabetes in Publicly Insured Children and Adolescents (PDF - 458KB)
• Pediatric Focused Safety Review: Abilify (aripiprazole) (PDF - 145KB)
• Open Meeting Presentation- Atypical Antipsychotics and Children (PDF - 52KB)
• Afluria Influenza Virus Vaccine: Pre-Licensure Safety Data (PDF - 122KB)
• Pediatric Safety and Utilization Review: AFLURIA (PDF - 359KB)
• FLUARIX Influenza Virus Vaccine: Review of Pre-Licensure Safety Data (PDF - 74KB)
• Pediatric Safety and Utilization Review: FLUARIX (PDF - 92KB)
• CDRH Safety Review of the Medtronic melody Transcatheter Pulmonary Valve (TPV) and Ensemble Transcatheter Valve Delivery System (PDF - 484KB)
• Melody TPV: Questions for the Committee (PDF - 11KB)
• Medtronic Presentation: Melody Transcatheter Pulmonary Valve (PDF - 1.1MB)
• Abbreviated and Expanded-Abbreviated Presentations (PDF - 289KB)
• Pediatric Focused Safety Review: Topamax (topiramate) (PDF - 313KB)
• Pediatric Focused Safety Review: Retrovir (zidovudine) (PDF - 315KB)
• Retrovir (zidovudine) Medication Errors (PDF - 30KB)
• Pediatric Focused Safety Review: Levaquin (PDF - 165KB)
• Informational Update: Kaletra Oral Solution Toxicity in Neonates—Lopinavir, Ethanol and/or Propylene Glycol? (PDF - 239KB)
• Why do we need another process and what is a "PAC Directed Abbreviated Review" (PDF - 29KB)