Summary

Development of the Pediatric Study Plan (PSP) for the United States Food and Drug Administration and the Pediatric Investigation Plan (PIP) for the European Medicines Agency (EMA) must be an integral part of the overall clinical development plan. Development of these plans should begin 1 to 2 years in advance of the anticipated start of the adult Phase 3 program. The Pediatric Research Equity Act (PREA, 2003, 2007)1, 2 gives the United States Food and Drug Administration (USFDA) the legal authority to mandate that drug developers conduct studies in children, unless the USFDA grants a specific waiver. The PIP laws from the European Parliament from 20073, 4 empower the EMA to require that drug developers conduct studies in children to support the authorization for medicines for children in the European Union (EU). The Better Pharmaceuticals for Children Act (BPCA)2 within the USFDA Modernization Act of 19975 in the United States awards drug developers an additional 6 months of market exclusivity, if the Sponsor conducts pediatric research as requested by the USFDA.

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Pediatric Product Development Plan

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