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For several years, FDA has advanced a policy of increasing diversity in clinical trial populations. During that time, FDA issued broad policy statements, as well as guidance on improved.

Drug administration safetyOffice of minority healthOffice of inspectorImprove enrollmentUnderrepresented racialEthnic populationsDraft guidanceClinical trialsAffordable care actMinority healthInnovation actAction planDemographic subgroup dataDraft guidance specifiesInvestigational new drugInvestigational device exemption