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Cardozo Public Law, Policy & Ethics Journal

Abstract

The note examines the effectiveness of the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA), which were enacted to address the lack of pediatric-specific drugs and devices. While these laws have improved the availability of pediatric treatments, they face significant challenges, including short authorization periods, loopholes exploited by pharmaceutical companies, and ethical concerns related to clinical trials. The 2007 reauthorization and the addition of the Pediatric Medical Device Safety and Improvement Act have partially addressed these issues but highlight the need for further reforms to ensure safer and more effective pediatric care.

Disciplines

Banking and Finance Law | Food and Drug Law | Law

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