Advancing evidence-based regulation: Organization for the Study of Sex Differences and Society for Women’s Health Research support FDA action on menopausal hormone therapy and encourage broader sex-informed drug label updates

Abstract Menopause is an important life-stage transition with substantial implications for health and quality of life. Menopausal hormone therapy (HT) remains among the most effective treatments for menopausal symptoms, yet clinical uptake has varied markedly over time as evidence regarding benefits and risks has evolved. The Organization for the Study of Sex Differences and the Society for Women’s Health Research outline our support for the US Food and Drug Administration’s (FDA) removal of the “black box” warning on menopausal HT labels. This important shift in federal policy supports evidence-based menopause care and reflects an evolving, evidence-responsive regulatory practice. We further call for consistent, evidence-based FDA review of whether approved product labeling adequately incorporates sex-related differences in pharmacokinetics, pharmacodynamics, and adverse event profiles, with updates to indications, dosing, and warnings where supported by robust data.