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Draft Guidance › Center for Drug Evaluation and Research (CDER) › Biologics

Ropes & Gray LLP

Anything Worth Doing Is Worth Doing Right: FDA Issues Draft Guidance on Requirements and Processes for Accelerated Approval

Ropes & Gray LLP on

On December 5, 2024, the U.S. Food and Drug Administration (“FDA”) issued a much anticipated draft guidance for industry on accelerated approval that provides additional clarity on FDA’s expectations for accelerated approval...more

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