Recently Updated Advisory Committee Materials

Recently Updated Advisory Committee Materials
Posted on December 07, 2010
Pediatric Advisory Committee

* Pediatric Focused Safety Review: Peginterferon alfa-2b (PegIntron) (PDF - 131KB)
* Pediatric Focused Safety Review: Flovent HFA (PDF - 274KB)
* Gardasil Post-Approval Adverse Event Review (PDF - 181KB)
* Neurodevelopmental Delays with Prenatal Valproic Acid Exposure: DNP Review Update (PDF - 66KB)
* Slides for the December 7, 2010 Meeting of the Pediatric Advisory Committee
* Pediatric Focused Safety Review: pegfilgrastim (Neulasta) (PDF - 90KB)
* Pediatric Focused Safety Review: Lamictal XR (lamotrigine extended-release) (PDF - 264KB)
* Pediatric Focused Safety Review: Darunavir Ethanolate (Prezista) (PDF - 116KB)
* Pediatric Focused Safety Review: Epiduo (PDF - 55KB)
* Pediatric Safety Review Xyzal (levocetirizine) (PDF - 184KB)
* Pre-licensure Safety Data: Gardasil (PDF - 79KB)
* Abbreviated Process for PAC - Acanya Gel and Ulesfia Lotion (PDF - 25KB)

full-text and articles, labels, guidelines, etc. [see days before]:
Recently Updated Advisory Committee Materials