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Clinical Trial Diversity Plans: Will US FDA Offer A Gentle Enforcement Hand?

 
• By Derrick Gingery

New guidance is due in a few months that should answer questions about how the FDA will react if a sponsor does not reach its clinical trial diversity goals.

diversity
Draft guidance on diversity action plans is due by the end of 2023. • Source: Shutterstock

MONTREAL – Sponsors may find an understanding and flexible US Food and Drug Administration enforcement approach to missed clinical trial diversity goals.

Eagerly anticipated guidance on the new clinical trial diversity plan mandate is expected by the end of the year, Jamie Gamerman, a senior policy advisor in the FDA Center for Drug Evaluation and Research’s Office of Medical Policy

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