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

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.

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...