Bloomberg Law
April 13, 2022, 4:55 PM

Drugmakers Get FDA Tips on Boosting Diversity in Clinical Trials (1)

Celine Castronuovo
Celine Castronuovo

Researchers seeking FDA approval to investigate new drugs or devices should submit plans for how they will incorporate Black Americans and other historically underrepresented groups in their trials, the agency said Wednesday.

The Food and Drug Administration published draft guidance for sponsors developing new drugs, biologic products, and medical devices to facilitate early planning for outreach to Blacks, Hispanics, and other minorities. Defining enrollment goals and data collection mechanisms for these groups can help researchers better examine how safety and efficacy may vary across different segments of a particular disease population.

The nonbinding recommendations are part of an ongoing effort ...

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