FDA holds public workshop on testosterone therapy for women

Food and Drug Administration (FDA) hosted a landmark public workshop titled "Testosterone Use in Menopausal Women."

This meeting marked a crucial step in addressing a significant medical gray area: while many menopausal women in the U.S. use testosterone "off-label," there are currently no FDA-approved testosterone products specifically designed or dosed for women.

The workshop, organized by the FDA’s Office of Women’s Health and the Center for Drug Evaluation and Research, aimed to bridge the gap between common clinical practices and official scientific evidence.

Experts from academia, the Cleveland Clinic, and the National Institutes of Health gathered to discuss critical topics, including the long-term safety of testosterone therapy—particularly its impact on cardiovascular health and breast cancer risk—as well as its potential benefits for mood, cognition, and bone health.

By opening a public comment docket until October 19, 2026, the FDA is inviting clinicians, researchers, and patients to share their experiences.

This collaborative effort is essential for establishing future regulatory pathways, ensuring that women have access to safe, effective, and well-researched medical options during the menopausal transition.