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FDA – Study of sex differences in the clinical evaluation of medical products

FDA has issued a draft guidance to provide recommendations for increasing enrolment of females in clinical trials, analysing and interpreting sex-specific data, and including sex-specific information in regulatory submissions of medical products. When finalized, this guidance will replace the guidance titled ‘Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs’ issued in July 1993. Comments can be submitted until 7th April 2025.

News reported on the 31st of January 2025 in Catapult’s regulatory round-up, read the entire report here.


OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (20 mai 2025). FDA – Study of sex differences in the clinical evaluation of medical products. ELSIBI. Consulté le 12 janvier 2026 à l’adresse https://doi.org/10.58079/13yf1


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