Non-binding Guidance: Clinical Trial Diversity in Focus

RopesTalk

On this episode of Ropes & Gray’s podcast series Non-binding Guidance, health care partner David Peloquin and life sciences regulatory and compliance counsel Sarah Blankstein discuss the FDA's recent draft guidance on diversity action plans (DAPs) aimed at improving the enrollment of underrepresented populations in clinical studies. They examine the implications and challenges sponsors may face in setting and meeting enrollment goals, as well as the potential impact of the recent presidential election on the final guidance. They also address key open questions related to the draft guidance.