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Pediatric Study Compliance Could Face Scrutiny In PDUFA Renewal

 
• By Sue Sutter

FDA says compliance is on par with other postmarketing requirements, but jury is still out on whether public posting of noncompliance letters has been effective tool to ensure timely trial completion.

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Questions around industry compliance with postmarketing requirements in the Pediatric Research Equity Act (PREA), and whether FDA has sufficient enforcement tools and incentives to ensure studies are timely completed, could be up for discussion in the next reauthorization of the Prescription Drug User Fee Act.

A recent Health and Human Services' Office of Inspector General report suggested PREA studies represented a high percentage of FDA...

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