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  • Regulatory NewsRegulatory News

    FDA Drafts Guidance on Enhancing Diversity in Clinical Trial Populations

    The US Food and Drug Administration (FDA) on Thursday issued a draft guidance aimed at increasing diversity in clinical trial populations as part of its efforts to encourage drugmakers to enroll populations that more closely reflect the populations that will take the drugs in the real world.   “This guidance recommends approaches that sponsors of clinical trials to support a new drug application [NDA] or a biologics license application [BLA] can take to broaden eligibi...