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In this section: Development Resources

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

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