Presentations

• Differin Lotion (adapalene): Pediatric Focused Safety Review (PDF - 156KB)
• Dulera Inhalation Aerosol (mometasone furoate and formotorol fumarate): Pediatric Focused Safety Review (PDF - 223KB)
• Gardasil Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant: Pre-licensure Review (PDF - 170KB)
• Gardasil Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant: Post-licensure Review (PDF - 272KB)
• Informational Update: Preliminary Data from a Pilot Study of Proton Pump Inhibitor Use in Infants <1 year in Intensive Care Units (PDF - 243KB)
• Menveo Meningoccoccal (Groups A,C,Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine: Pre-licensure Review (PDF - 75KB)
• Menveo Meningoccoccal (Groups A,C,Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine: Post-licensure Review (PDF - 223KB)
• MultiHance Injection (gadobenate dimeglumine): Pediatric Focused Safety Review (PDF - 170KB)
• Nasonex (mometasone furoate monohydrate): Pediatric Focused Safety Review (PDF - 145KB)
• Tamiflu- CDC: Epidemiology in Influenza in Children and Clinical Complications (PDF - 2.4MB)
• Tamiflu- Surveillance of Adverse Events Associated with Oseltamivir in a Healthcare Claims Database (PDF - 353KB)
• Tamiflu - Tamiflu® (Oseltamivir) Safety Assessment, Vaccine Safety Datalink Project, 2007-2010 (PDF - 802KB)
• Tamiflu (oseltamivir):- Pediatric Focused Safety Review (PDF - 280KB)
• Tamiflu - Tamiflu (oseltamivir phosphate): Background Information and Drug Utilization Patterns (PDF - 97KB)
• Taxotere, Omnaris Nasal Spray, Natazia and Protonix: Pediatric Focused Safety Review (PDF - 301KB)
• Post-marketing Monitoring of Vaccine Safety (PDF - 304KB)
• Viread (tenofovir disoproxil fumarate): Pediatric Focused Safety Review (PDF - 210KB)