Pediatric Study Delays Could Draw Civil Penalties Under Proposal For PREA, BPCA Reauthorization
By
Cathy Dombrowski / Email the Author / “The Pink Sheet” DAILY Feb. 1, 2012
Word Count: 947 / Article # 14120201007
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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