FDA Announces Public Workshop on Testosterone Use in Menopausal Women: Informing Future Research and Regulation

What this means for your practice

This FDA public workshop signals a focused effort by the agency to address the complex and evolving landscape of testosterone use in menopausal women. For telehealth providers, medspas, and other healthcare businesses offering hormone replacement therapies (HRT), this initiative is significant. While not an immediate regulatory change, it indicates the FDA is actively gathering scientific data and stakeholder input that will likely inform future guidance, labeling requirements, and potentially new drug approvals. Practices currently prescribing testosterone off-label for menopausal women should pay close attention to the scientific discussions and regulatory considerations highlighted in this workshop. Understanding the FDA's perspective on efficacy, safety, measurement challenges, and long-term outcomes is crucial for maintaining compliant and evidence-based practices. Participation in the comment period offers an opportunity to contribute to the scientific and regulatory dialogue, influencing the future framework for testosterone therapies.

Washington D.C. — The U.S. Food and Drug Administration (FDA), through its Office of Women's Health and the Center for Drug Evaluation and Research, has announced a public workshop titled “Testosterone Use in Menopausal Women.” This event is designed to critically examine the existing scientific evidence and identify key knowledge gaps pertaining to the use of testosterone in menopausal women. The insights gathered from this workshop are intended to guide future research endeavors and potential drug development efforts for testosterone products targeting this specific demographic.

Purpose of the Public Workshop

The FDA's initiative reflects a growing interest in understanding the physiological and clinical aspects of testosterone in women, particularly during and after menopause. The workshop's primary objective is to facilitate a robust scientific discussion that will help shape a clearer regulatory path for any potential marketing applications for testosterone in menopausal women. This includes addressing the treatment of various clinical conditions where testosterone might play a role.

Key Discussion Areas and Topics

The workshop agenda is comprehensive, featuring presentations and discussions from researchers, educators, industry representatives, clinicians, patients, and consumers. Specific topics slated for examination include:

• Physiological Roles of Testosterone: An exploration of testosterone's functions throughout a woman's life, including natural age-related decline.
• Menopausal Transition: Focus on how testosterone levels change and impact women during the menopausal transition.
• Measurement and Interpretation Challenges: A review of the difficulties associated with accurately measuring and interpreting testosterone blood levels in women, and how these levels correlate with clinical symptoms and conditions.
• Current and Potential Clinical Uses: An evaluation of the existing and prospective clinical applications of testosterone in menopausal women, alongside an assessment of the strengths and limitations of supporting data.
• Regulatory Considerations: Discussion on the requirements for developing robust efficacy and safety data necessary to support a marketing application for testosterone in menopausal women.
• Study Design for Long-Term Safety: Examination of considerations for designing studies to effectively evaluate the long-term safety outcomes of testosterone use in women.

Workshop Logistics

The public workshop is scheduled to be held on September 17, 2026, from 9:00 a.m. to 4:30 p.m. Eastern Time. The event will be conducted in a hybrid format, allowing for both virtual attendance via webcast and an in-person option. The in-person component will take place at the FDA White Oak Campus, Great Room, Bldg. 31, 10903 New Hampshire Ave., Silver Spring, MD 20993.

Attendees opting for in-person participation (non-FDA employees) should enter through Building 1, where standard security procedures will be performed. Further details regarding registration dates, visitor parking, and campus security can be found in the SUPPLEMENTARY INFORMATION section of the original Federal Register notice and on the FDA's visitor information webpages.

Submitting Public Comments

In conjunction with the workshop, the FDA is soliciting public comments, data, and information from all interested stakeholders. This provides a crucial opportunity for the healthcare community, industry, patient advocates, and the public to contribute to the FDA's understanding of this important medical topic.

Comment Submission Deadline: Comments will be accepted until 11:59 p.m. Eastern Time on October 19, 2026. Late submissions will not be considered.

Methods of Submission:

• Electronic Submissions: Comments can be submitted via the Federal eRulemaking Portal at https://www.regulations.gov. Users should follow the instructions provided on the portal. It is important to note that electronic comments, including attachments, will be posted publicly. Submitters are responsible for ensuring that no confidential information is included in public electronic submissions.
• Written/Paper Submissions: Comments can be mailed or hand-delivered to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written submissions, FDA will post comments publicly unless specifically marked and identified as confidential, following the detailed instructions for confidential submissions.

Confidential Submissions: To submit comments containing information not intended for public disclosure, only written/paper submissions are accepted. Two copies should be submitted: one clearly marked “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION” and a second, redacted copy, with the confidential information removed.

All submissions must include Docket No. FDA-2026-N-5479 for “Testosterone Use in Menopausal Women; Public Workshop; Request for Comments.” Received comments will be publicly viewable on https://www.regulations.gov or at the Dockets Management Staff during business hours, except for those properly submitted as confidential.

This workshop represents a proactive step by the FDA to gather essential scientific and clinical perspectives, which will be instrumental in shaping future regulatory approaches to testosterone therapy for menopausal women. Stakeholders are strongly encouraged to participate and provide input.

Key Facts

| Detail | Value | |---|---| | Agency | Food and Drug Administration (FDA), HHS | | Document Type | Notice of public workshop | | Docket Number | FDA-2026-N-5479 | | Workshop Date | September 17, 2026, from 9:00 a.m. to 4:30 p.m. Eastern Time | | Comment Deadline | October 19, 2026, by 11:59 p.m. Eastern Time | | Purpose | Examine scientific evidence and knowledge gaps related to testosterone use in menopausal women to inform future research and potential drug development. |

Frequently Asked Questions

What is the purpose of the FDA's public workshop on testosterone use in menopausal women?

The workshop aims to examine current scientific evidence and critical knowledge gaps related to testosterone use in menopausal women, to help inform future research and potential drug development of testosterone products for this population.

Who is encouraged to attend this workshop?

Researchers, educators, industry, clinicians, patients, and consumers may benefit from attending this scientific workshop.

What specific topics will be discussed at the workshop?

Speakers will examine physiological roles of testosterone, age-related decline, the menopausal transition, challenges in measuring testosterone levels, correlation with clinical symptoms, current and potential clinical uses, regulatory considerations for marketing applications, and study design for evaluating long-term safety outcomes.

When and where will the workshop take place?

The workshop will be held on September 17, 2026, from 9:00 a.m. to 4:30 p.m. Eastern Time, as a hybrid event via webcast and in-person at the FDA White Oak Campus, Great Room, Bldg. 31, Silver Spring, MD 20993.

What is the deadline for submitting comments to the FDA regarding this topic?

Comments must be submitted by 11:59 p.m. Eastern Time at the end of October 19, 2026.

Source: FDA — Notice: Testosterone Use in Menopausal Women; Public Workshop; Request for Comments · 2026-08-18