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Pediatric Study Delays Could Draw Civil Penalties Under Proposal For PREA, BPCA Reauthorization

This article was originally published in The Pink Sheet Daily

Executive Summary

Civil penalties would be more flexible than FDA’s current authority to label a drug misbranded if sponsors fail to conduct pediatric studies, Commissioner Hamburg argues as the House Energy and Commerce Committee’s Health Subcommittee opens hearings on reauthorizing prescription drug user fees.

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