US lawmakers showed strong support for attaching to Food and Drug Administration user fee legislation provisions aimed at increasing the diversity of clinical trials, but whether those measures will impose enforceable obligations on sponsors, or merely incentivize more diverse enrollment, remains to be seen.
Clinical Trial Diversity Measures Primed For Inclusion In US FDA User Fee Legislation
House subcommittee hears testimony on merits of various proposals to increase diversity of clinical trial participants; whether lawmakers ultimately favor measures that impose enforceable obligations on sponsors, or merely incentivize more diverse enrollment, remains to be seen.
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The US Health and Human Services Secretary nominee’s commitment should be a positive sign for those who want to ensure Americans can access adequate data on drugs in all populations that could use them.
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