Premarket Pivotal Trial End Points and Postmarketing Requirements for FDA Breakthrough Therapies
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Patel N, Mohammad A, Ross J, Ramachandran R. US FDA breakthrough therapy designation and consumer drug advertising: a recipe for confusion. The BMJ 2024, 384: e076138. PMID: 38383007, DOI: 10.1136/bmj-2023-076138.Peer-Reviewed Original Research