Diversity Action Plans Should Be Brief And Waiver Requests Filed Early, US FDA Says

In what could amount to a de facto enforcement mechanism, the new draft guidance also “strongly encourages” sponsors to share details about their diversity action plan and enrollment goals with the public.

Diverse hands
The FDA expects studies can be conducted with diversity action plans 'in most cases.' • Source: Shutterstock

[Editor's note: A version of this story appeared first in our sister publication, Pink Sheet.]

The US Food and Drug Administration wants new clinical trial diversity action plans to be short and waiver requests filed early, albeit

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