T Time: Women Were First to Put Testosterone Back on FDA’s Agenda. Now It’s Industry’s Turn🔒 SSL Verified

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"More than two decades after FDA last publicly grappled with the development of testosterone for women, the Agency is asking industry to take another look."

"On September 17, 2026, FDA’s Office of Women’s Health (OWH) and the Center for Drug Evaluation and Research (CDER) convened a public workshop on testosterone use in menopausal women. The day-long meeting brought together clinicians, researchers, patients, and FDA officials to discuss what is known, what remains unknown, and, importantly for drug developers, what it may take to develop an FDA-approved testosterone product for women."

"But perhaps the most remarkable part of the meeting was why it happened at all: women asked for it."

"The roots of the workshop can be traced, at least in part, to FDA’s December 2025 public meeting on testosterone replacement therapy in men. More than 80% of comments submitted to the public docket following that meeting came from women, many calling attention to the lack of an FDA-approved testosterone product for women. At last week’s workshop, FDA repeatedly acknowledged the role those voices played in bringing the issue to the forefront."

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