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Draft Guidance › Center for Drug Evaluation and Research (CDER) › Clinical Trials

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Anything Worth Doing Is Worth Doing Right: FDA Issues Draft Guidance on Requirements and Processes for Accelerated Approval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On December 5, 2024, the U.S. Food and Drug Administration (“FDA”) issued a much anticipated draft guidance for industry on accelerated approval that provides additional clarity on FDA’s expectations for accelerated approval...more

Health Care Compliance Association (HCCA)

Draft Guidance to Increase Seniors in Cancer Trials a 'Good First Step'

Health Care Compliance Association (HCCA) on

Report on Research Compliance 17, no. 5 (May 2020) - Study sponsors should be making additional efforts to enroll older individuals in cancer trials, incorporating such strategies in study design and recruitment methods,...more

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