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Clinical Trial Diversity: User Fee Bill Wants FDA’s Assessment Of Whether It Needs More Authority

 
• By Brenda Sandburg

HHS is to evaluate the need for FDA authority to mandate postapproval studies or postmarket surveillance if sponsors do not meet diversity enrollment goals. By contrast, the DEPICT Act would have given the agency the authority to do so.

Diversity
FDA user fee bill includes provisions on improving diversity in clinical trials • Source: Shutterstock

Legislation to extend the Food and Drug Administration’s user fee programs has taken a softer approach to the agency’s oversight of clinical trial diversity than another bill pending in Congress. Rather than giving the FDA authority to mandate postmarketing studies if a sponsor does not meet its diversity enrollment goals, the legislation calls for the Secretary of the Department of Health and Human Services to evaluate whether the agency needs such authority.

The House FDA user fees package, released by the Democratic and Republican leadership of the House Energy and Commerce Committee on 4 May, reauthorizes the Prescription Drug User Fee...

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