FDA addresses biopharma's diversity problem with new draft guidance
Back in 2020 — as drugmakers struggled to enroll diverse populations in Covid-19 trials — the FDA released new guidance urging pharma companies to devise a plan for making their studies more inclusive. In its latest draft guidance, the agency is filling in more of the details.
The FDA provided a draft framework on Wednesday for drugmakers and medical device manufacturers regarding plans to enroll more diverse trial participants. Part of that framework includes setting goals for enrollment and specifying retention strategies, such as providing language assistance and reducing the burdens of participation with tools like telehealth.
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