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Diversity Sponsors

BakerHostetler

FDA Issues Draft Guidance on Diversity Action Plans

BakerHostetler on

On June 26, 2024, the U.S. Food and Drug Administration (FDA) issued draft guidance setting forth detailed requirements for the submission of Diversity Action Plans (DAPs) by sponsors of certain clinical studies involving...more

Goodwin

FDA Issues Overdue Draft Guidance on Clinical Trial Diversity Action Plans

Goodwin on

Yesterday, the U.S. Food and Drug Administration (FDA) released its long-awaited draft guidance on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies....more

Baker Donelson

Should Your Organization Consider a Sponsorship Program?

Baker Donelson on

Should your organization consider a sponsorship program? Absolutely! An important aspect of an organization's ability to attract and retain engaged and committed employees is how the organization brings out the best in its...more

Goodwin

Clinical Trial Diversity Plans and Rare Diseases

Goodwin on

Clinical trial diversity is not a new concept–the U.S. Food and Drug Administration (FDA) issued a draft guidance providing specific recommendations to industry on how to improve diversity in clinical trials in April 2022...more

Foley Hoag LLP

FDA Issues Draft Guidance Recommending "Race and Ethnicity Diversity" Plans for Clinical Trial Sponsors

Foley Hoag LLP on

Key Takeaways: The draft guidance represents the first-ever specific expectation by FDA that sponsors develop a diversity plan for trials. FDA’s recommendations come as part of increasing interest in ensuring clinical...more

Dechert LLP

The Olympic Games: Citius, Altius, Fortius and Litigious?

Dechert LLP on

The Games of the XXXII Olympiad will soon begin. They will be played under the Olympic motto of Citius, Altius, Fortius (faster, higher, stronger). But to what extent will the Games also be litigious?  ...more

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