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Expert Analysis

The Fate Of Biden-Era Clinical Study Guidance Under Trump

By Eva Temkin, Phil Desjardins and Liz Lindquist ( February 21, 2025, 6:53 PM EST) -- Among the flurry of U.S. Food and Drug Administration guidance documents issued in early January by the outgoing Biden Administration were two guidance drafts addressing the study and evaluation of sex and gender differences in medical product development: "Study of Sex Differences in the Clinical Evaluation of Medical Products"[1] and "Evaluation of Sex-Specific and Gender-Specific Data in Medical Device Clinical Studies."[2]...

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