Advisory Committees
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Presentation Slides for the January 30-31, 2012 Meeting of the Pediatric Advisory Committee
Persons with disabilities having problems accessing any of the PDF files below may call (301) 796-3634 for assistance.
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Presentations
Pediatric Focused Safety Review: Focalin® and Focalin XR® (dexmethylphenidate hydrochloride) and Daytrana® (methylphenidate transdermal system) (PDF - 607KB)Pediatric Focused Safety Review: Seroquel® (quetiapine fumarate) (PDF - 418KB)Pediatric Focused Safety Review: Xolair® (Omalizumab) (PDF - 195KB)Pediatric Focused Safety Review: Plan B® One-Step (levonorgestrel) (PDF - 121KB)Pediatric Focused Safety Review: Flomax® (tamsulosin hydrochloride) (PDF - 127KB)Pediatric Focused Safety Review: ATACAND® (candesartan cilexitil) (PDF - 176KB)Pediatric Focused Safety Review: Benicar® (olmesartan medoxomil) (PDF - 145KB)Review of Pre-Licensure Safety Data and and Post-licensure Pediatric Safety and Utilization Review: Prevnar 13 Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein] (PDF - 203KB)Pre-licensure Safety Data: CERVARIX [Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant] (PDF - 56KB)Pediatric Safety and Utilization Review: CERVARIX [Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant] (PDF - 210KB)Pediatric Formulations: NIH-FDA Cooperative Efforts (PDF - 5.2MB)Pediatric Formulations: Some Challenges in the Development (PDF - 839KB)Pediatric Formulations: Clinical Pharmacology Issues (PDF - 123KB)
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