Confirmatory trials of drugs granted accelerated approval should represent the diversity of patients expected to use the drug in the US, the Food and Drug Administration tells sponsors in a new draft guidance on postmarketing approaches to obtaining data on populations underrepresented in clinical trials.
FDA Postmarket Guidance Hammers Home Positions On Foreign Trials, Real-World Evidence
US agency emphasizes and formalizes long-standing viewpoints on hot topics including accelerated approval in a new guidance on postmarket study diversity.
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