Last week, Theresa Gaffney reported in STAT’s Morning Rounds: The FDA put out about two dozen draft guidance documents and policies. “In my 15+ years of analyzing the FDA, today is unquestionably one of the busiest days for the release of new guidances and policies that I have ever seen,” industry expert Alexander Gaffney posted on X. These provide instruction — that, to be clear, is not legally binding — on topics like drug compounding, limits on lead in baby food, and more. 

STAT’s Katie Palmer wrote about the FDA’s first draft guidance on the use of artificial intelligence in the development of drugs and biological products. STAT’s Usha Lee McFarling and Anil Oza wrote about long-awaited guidance on how manufacturers should test and label pulse oximeters to improve their accuracy for all skin tones.

Gaffney notes she is particularly interested in the new draft guidance emphasizing the importance of gathering more diverse sex and gender data in clinical studies for medical products, and including pregnant people in those trials as well. The agency doesn’t have a definitive answer to the larger question of how to collect this data, however: “One approach may be to ask study participants for both their sex assigned at birth and their current gender identity,” the guidance states.

The guidance suggests a few strategies to improve sex and gender diversity in study enrollment, like targeting more diverse clinics and building relationships with community groups. It also recommends assessing existing literature on a disease or condition to inform if, or how, to look for sex-based differences in its prevalence or treatment. 

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New Year, New Docs: FDA Drops Dozens of Draft Guidances

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