Advisory Committees
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Slides for the May 16, 2011 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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Slides
Abbreviated Process for PAC- No Presentation (PDF - 30KB)Haemophilus b Conjugate Vaccine: Review of Pre-Licensure Safety Data (PDF - 69KB)Pediatric Safety and Utilization Review: Booster Dose of HIBERIX (PDF - 230KB)Pediatric Focused Safety Review: INTUNIV (PDF - 177KB)Pediatric Focused Safety Review: escitalopram oxalate (Lexapro) (PDF - 214KB)Pediatric Focused Safety Review: Valganciclovir Hydrochloride (Valcyte) (PDF - 112KB)Topical Calcineurin Inhibitors Pediatric Safety Update: Regulatory Background (PDF - 114KB)Topical Calcineurin Inhibitors and Malignancies in Pediatric Patients: A Literature Review (PDF - 154KB)Update on Post-Marketing AERS Cases of Pediatric Malignancies Reported With Topical Pimecrolimus and Tacrolimus Use (PDF - 146KB)Paul Aftring, Novartis Pharmaceuticals: Pimecrolimus Cream 1% (Elidel) (PDF - 42KB)Joyce Rico, Astellas Pharma Global Development: Topical Tacrolimus Ointment (Protopic) (PDF - 691KB)- Open Public Hearing Presentation: Lawrence Eichenfield, Topical Calcineurin Inhibitor (TCI) and Children (PDF - 108KB)
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