Pediatric Study Statistics and Reviews

The  information on this page pertains to the implementation of the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA).

Pediatric Tracking Requirements Under FDAAA

• Pediatric Tracking Requirements Under FDAAA
• Breakdown of FDAAA Completed Pediatric Studies

Written Requests

• Written Requests Issued
• List of Determinations Including Written Request
• Pediatric Exclusivity Granted
• Pediatric Exclusivity Statistics 

Medical, Statistical, and Pharmacology Reviews

• Medical, Statistical, and Pharmacology Reviews 7/9/2012- present 
• Medical, Statistical and Pharmacology Reviews 9/2007- 7/2012 
• Medical, Statistical and Pharmacology Review Summaries 1/2002-9/2007