Workshop To Enhance Clinical Study Diversity; Public Workshop; Request for Comments
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The Food and Drug Administration (FDA, the Agency, or we) is announcing a public workshop entitled "Workshop To Enhance Clinical Study Diversity." This public workshop will satisfy a mandate of the Food and Drug Omnibus Reform Act of 2022 (FDORA) for FDA to convene one or more public workshops to solicit input from various stakeholders on enhancing diversity in clinical studies.The public workshop will be convened and supported by a cooperative agreement between FDA and the Clinical Trials Transformation Initiative and will solicit input from interested parties on increasing the enrollment of historically underrepresented populations in clinical studies and encouraging clinical study participation that reflects the prevalence or incidence of the disease or condition among demographic subgroups, where appropriate.
Abstract as published in the Federal Register.
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