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Clinical Trial Diversity Action Plans Need Timely US FDA Feedback, Groups Say

 
• By Sue Sutter

Industry organizations argued feedback should be expected and object to draft guidance language suggesting it may be optional. The agency also should apply waiver criteria flexibly and address potential consequences if enrollment goals are not met, stakeholders say.

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

The US Food and Drug Administration should provide timely feedback on biopharma sponsors’ clinical trial diversity action plans and explain its enforcement approach if goals are not met, industry and patient groups said.

Key Takeaways

  • The FDA should commit to reviewing and providing feedback on diversity action plan proposals within a certain timeframe, draft guidance comments state.

  • Industry and rare disease stakeholders urged the agency to be flexible when applying criteria for DAP requirement waivers

In comments on a June draft guidance on diversity action plans, stakeholders also asked the FDA to clarify the studies that will require DAPs

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