Module232025

12/05/2025

BPCA

• FDA may issue a Written Request (WR) to a sponsor for voluntary pediatric studies that may lead to health benefits in that population • Companies submit Proposed Pediatric Study Request (PPSR) • Sponsors who submit studies fulfilling a WR are eligible to receive pediatric exclusivity • If the terms of the WR have been met and studies were conducted using good scientific principles, the company is eligible for pediatric exclusivity • Additional 6 months of exclusivity • Exclusivity attached to all existing marketing exclusivities and patents for the drug moiety (initial WR) • Pediatric exclusivity does not require positive pediatric studies

The Organisation for Professionals in Regulatory Affairs

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iPSP Assessment Timeline

The Organisation for Professionals in Regulatory Affairs

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