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In this section: Development Resources

Pediatric Review Committee (PeRC)

PeRC is an internal committee established under the Food and Drug Administration Amendments Act (FDAAA) to carry out activities related to BPCA and PREA.

Internal Review Committee - Memorandum Establishing Pediatric Review Committee
PMHS Standard Operating Procedure (SOP) for Review of Pediatric Study Plans (PSPs) and Written Requests by the Pediatric Review Committee (PeRC) (PDF - 51 KB)
Fulfills requirement of Section 503 of FDASIA.

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