The FDA says companies that make drugs should submit plans for how they will increase the number of Blacks and other underrepresented groups in clinical trials, the agency said Wednesday.
The U.S. Food and Drug Administration says companies that produce drugs and other medical products should submit plans for how they will increase the number of Blacks and other underrepresented groups in clinical trials, the agency said Wednesday.
For drugs being tested, companies should submit such a plan “as soon as practicable” during drug development but no later than when the sponsor or company is seeking feedback for the clinical trials, the draft guidance said. “The U.S. population has become increasingly diverse, and ensuring meaningful representation of racial and ethnic minorities in clinical trials for regulated medical products is fundamental to public health,” FDA Commissioner Robert M. Califf, MD, said in a news release.
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