As part of President Donald Trump’s directive to eliminate anything construed as related to diversity, equity and inclusion (DEI), the US Food and Drug Administration (FDA) has revised a decade-old guidance on using sex-specific data in medical device clinical studies. The reissued guidance also eschews a modernized version of the guidance proposed in the final weeks of the Biden Administration.
Immediately upon taking office in January, Trump signed an executive order to remove any DEI initiatives, programs, or in some cases even mentions of gender, race, or diversity from federal documents or programs. This led to the removal of FDA’s clinical trial diversity action plans draft guidance and portions of FDA’s website that were construed as being related to DEI…
