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"FDORA requires drug and device sponsors to submit clinical trial Diversity Action Plans to FDA ahead of pivotal clinical studies, including the sponsor’s goals for enrollment in the trial, the rationale for these goals, and an explanation for how the sponsor intends to meet those goals. Such goals must be disaggregated by age group, sex, and racial and ethnic demographic characteristics of clinically relevant study populations. FDORA also required FDA to issue guidance outlining the form and content of Diversity Action Plan submissions sponsors must follow and provide recommendations for sponsors on other aspects of the plans."