For the April 12, 2016 meeting of the FDA's Pediatric Advisory Committee

Persons with disabilities having problems accessing any of the PDF files below may call 240-402-3838 for assistance.

Briefing Materials

• PRECEDEX Labeling, 7/2015
• PRECEDEX Safety and Drug Utilization Review
• Presentation: Pediatric Focused Safety Review Precedex (dexmedetomidine)
• PRECEDEX Clinical Review
• PRECEDEX Clinical Pharmacology Review
• PRECEDEX Statistical Review

ResourcesForYou

• Products and Briefing Materials for the April 12, 2016 Meeting of the Pediatric Advisory Committee
• 2016 Meeting Materials, Pediatric Advisory Committee