Report of the FDA’s expert panel on hormone therapy

The FDA convened an expert panel on July 17, 2025, to review evidence on the benefits and risks of menopausal hormone therapy. Several members of The Menopause Society who served on the expert panel summarize the meeting, including panelists’ presentations and future directions. The FDA selected a multidisciplinary group of researchers and clinicians based on their expertise, clinical and academic credibility, leadership, and advocacy in caring for menopausal women’s health. The panel emphasized the differences between systemic and local vaginal estrogen and the adverse effects of class labeling and the boxed warning, especially for local vaginal estrogen. The panel discussed differences in risk profiles between estrogen alone and estrogen combined with different types of progestogens, and the importance of formulation, route of administration, dosing, and timing of initiation. Following this discussion, a 60-day public commentary period, and an independent review of the literature, on November 10, 2025, the FDA recommended removing boxed warnings from estrogen therapies, with specific, nuanced considerations.