Michael Purcell

Michael Purcell

Ropes & Gray LLP

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Anything Worth Doing Is Worth Doing Right: FDA Issues Draft Guidance on Requirements and Processes for Accelerated Approval

On December 5, 2024, the U.S. Food and Drug Administration (“FDA”) issued a much anticipated draft guidance for industry on accelerated approval that provides additional clarity on FDA’s expectations for accelerated approval...more

12/20/2024  /  Biologics , Center for Drug Evaluation and Research (CDER) , Clinical Trials , Draft Guidance , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Life Sciences , Pharmaceutical Industry , Prescription Drugs
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