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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