Best Pharmaceuticals for Children Act (BPCA)
BPCA provides an incentive of additional marketing exclusivity to sponsors who voluntarily complete pediatric clinical studies outlined in a Written Request issued by FDA.
- Written Requests Issued
List of approved active moieties and the sponsor to whom the written request was issued.
- Pediatric Formulations Developed to Earn Pediatric Exclusivity But Not Marketed (PDF - 19 KB)
- Pediatric Formulations Unable to be Developed