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