User Fee Bill Requires Sponsors To Submit Trial Diversity Plans To FDA

House lawmakers’ draft user fee legislation includes several measures aimed at increasing diversity in clinical trials, including a requirement that drug and device sponsors provide FDA with diversity action plans that lay out their trial enrollment goals and explain how they plan to meet those goals. The legislation also calls for FDA to issue draft guidance on trial diversity plans and decentralized clinical trials, provide a public report summarizing the diversity action plans, and hold a public meeting on trial...