Federal Register #FDA-2026-N-5479

FDA Public Workshop: Testosterone Use in Menopausal Women

The Food and Drug Administration (FDA) is hosting a public workshop focused on testosterone use in menopausal women. - Organized by the Office of Women's Health and the Center for Drug Evaluation and Research - Workshop aims to examine current scientific evidence and identify knowledge gaps - Topics include: - Physiological roles of testosterone in women - Challenges in measurement and clinical use - Regulatory considerations for drug development - Study design for long-term safety outcomes - Intended audience includes researchers, educators, industry, clinicians, patients, and consumers - No products or services are being procured; no OEMs or vendors are mentioned - Public comments are invited to guide future regulatory and research directions

Description

The Food and Drug Administration's (FDA) Office of Women's Health and the Center for Drug Evaluation and Research are hosting a public workshop to examine the current scientific evidence and knowledge gaps related to testosterone use in menopausal women. The workshop aims to inform future research and potential drug development of testosterone products for menopausal women. Topics include physiological roles of testosterone, challenges in measurement, clinical uses, regulatory considerations, and study design for long-term safety outcomes. The event is intended for researchers, educators, industry, clinicians, patients, and consumers.

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