Evelyn Pereira

Evelyn Pereira

King & Spalding

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FDA Issues Draft Guidance on Accelerated Approval Focused on How the Agency Will Implement New Authorities

On December 5, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled Expedited Program for Serious Conditions—Accelerated Approval of Drugs and Biologics (Draft Accelerated Approval...more

1/7/2025  /  Applications , Clinical Trials , Consolidated Appropriations Act (CAA) , Draft Guidance , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA)
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