The US Food and Drug Administration (FDA) is proposing to update two guidance documents that clarify terminology around sex and gender of clinical trial participants in an effort to improve the understanding of medical products’ effects on women.
Both documents are guidance updates to older documents and are open for public comment through 7 April 2025.
One of the new draft guidance documents – Study of Sex Differences in the Clinical Evaluation of Medical Products – will replace guidance on “gender differences” issued in July 1993 once finalized. The 20-page guidance draft applies to trials of drugs, biological products, or medical devices intended for humans, whereas the 1993 version was focused on the study of drugs…
