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Science and Politics May Collide As US FDA Offers More Precise Definitions Of Sex And Gender

 
• By Sarah Karlin-Smith

The draft guidance clarifies that sex and gender are not interchangeable, but could be vulnerable in the Trump Administration as Republicans have argued against transgender medical care and that sex and gender must be congruent.

Two traffic signs that say "sex" and "gender" pointed in different directions.
New FDA draft guidance clarifies the difference between sex and gender. (Shutterstock)
Key Takeaways
  • Before the FDA delves into the statistical issues with studying sex differences in clinical trials in a new draft guidance, it clarifies that it has not always used sex and gender language precisely and outlines upcoming changes.
  • The guidance states that the terms sex and gender are not interchangeable.
  • The guidance may be controversial since Republicans have targeted transgender people on the basis that sex and gender should align.

A new US Food and Drug Administration draft guidance clarifies the difference between sex and gender, acknowledging the agency has often used the terms interchangeably...

The guidance’s acknowledgement that sex and gender are not interchangeable, comes at a tense time in US political discourse about the issue. Republicans have been trying

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