1. Pink Sheet

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Industry organizations argued feedback should be expected and object to draft guidance language suggesting it may be optional.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.

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