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FDA Scrubs ‘Gender’ From Final Guidance On Sex-Specific Data But Encourages More Women In Clinical Trials

 
• By Brian Bossetta

The US FDA has published its final document to guide sponsors on using sex-specific data in designing clinical trials of medical devices. However, the guidance removes all references to gender that appeared in January’s draft guidance, released before the Trump administration took office.

Women in Health Care
(Shutterstock)

In final guidance released on 2 April —“Evaluation of Sex-Specific Data in Medical Device Clinical Studies”— the US Food and Drug Administration makes recommendations on how to include more women in clinical trials but has removed the word “gender” in keeping with the executive order Trump signed upon taking office eliminating anything related to diversity, equity and inclusion, or DEI, in the federal government.

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