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CDRH Report: 24 Voluntary Diversity Action Plans Filed In 2024

 
• By Elizabeth Orr

While the US FDA will not require diversity action plans for clinical trials for a while, some companies are already sending them in, a new FDA report to Congress shows.

Diversity paper cutouts
Sponsors' clinical trial diversity action plans would benefit from FDA feedback, industry groups said. • Source: Shutterstock

Diversity action plans are starting to trickle into the US Food and Drug Administration’s Center for Devices and Radiological Health, a new report to Congress shows.

The FDA compiled the report under 2023’s Food and Drug Omnibus Reform Act (FDORA), which mandated that the agency ask for diversity action plans for some clinical trials. In June, the FDA issued a draft guidance document detailing how it plans to implement the new requirement

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