Clinical Trial Diversity Action Plan Waivers Will Be ‘Very Rare,’ US FDA Official Says

With the much-anticipated guidance still pending, OCE’s Tamy Kim reminds industry of the requirements and timing around avoiding the soon-to-be requirements on study enrollments.

Hundreds of diverse headshots
Sponsors should be prepared to check all the boxes on diversity action plans and not anticipate a waiver. • Source: Shutterstock

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