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US FDA Says Restored Webpages Do Not Reflect ‘Biological Reality’

 
• By Sue Sutter

Clinical trial draft guidance webpages are back online following a court order, but with new language disclaiming any information promoting gender ideology as "extremely inaccurate."

DAP Website with Statement
The clinical trial diversity action plan guidance webpage now includes a disclaimer about "gender ideology." (Screenshot of FDA Website)
Key Takeaways
  • Under court order, the US FDA restored webpages for draft guidances on clinical trial diversity action plans and sex differences in clinical investigations of medical products.
  • However, the restored pages now include a disclaimer related to President Trump’s executive order targeting “gender ideology extremism.”
  • Doctors for America wants additional FDA pages restored, including resources focused on health equity and women’s health.

The fight over disappearing resources from the US Food and Drug Administration’s website is expanding even as the agency restores deleted guidance documents and other pages, albeit with a new...

Webpages for draft guidances on clinical trial diversity action plans and sex differences in clinical evaluation of medical products were restored on 11 February, pursuant to a temporary restraining order...

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