ARTICLE | Regulation
FDA’s clinical trial diversity guidance offers road map for compliance
Agency’s latest guidance is the first since diversity action plans became mandatory
July 16, 2024 11:46 PM UTC
FDA’s latest draft clinical trial diversity guidance is designed to help manufacturers meet the requirements of the FD&C Act, but does not spell out consequences for failing to meet diversity enrollment goals. Once the guidance has been finalized, parts of it will be binding.
Announced June 26, the draft guidance was developed by FDA’s Oncology Center of Excellence in collaboration with CDER, CBER, the Center for Devices and Radiological Health, the Office of Women’s Health and the Office of Minority Health and Health Equity. ...
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