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Food and Drug Administration, HHS.
Notice of public workshop.
The Food and Drug Administration's (FDA) Office of Women's Health and the Center for Drug Evaluation and Research are announcing a public workshop titled “Testosterone Use in Menopausal Women.” The purpose of the public workshop is to examine the 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 menopausal women. Researchers, educators, industry, clinicians, patients, and consumers may benefit from attending this scientific workshop. Presentations will examine the physiological roles of testosterone throughout a woman's life, including age-related decline, the menopausal transition, challenges associated with measuring and interpreting testosterone blood levels, and how these levels correlate with clinical symptoms and conditions. Speakers will review current and potential clinical uses of testosterone in menopausal women and examine the strengths and limitations of available data supporting those uses. Speakers will discuss regulatory considerations, including the development of robust efficacy and safety data, to support a marketing application for testosterone in menopausal women for the treatment of various clinical conditions, and study design considerations for evaluating long-term safety outcomes in women.
The public workshop will be held on September 17, 2026, from 9:00 a.m. to 4:30 p.m. Eastern Time. See the SUPPLEMENTARY INFORMATION section for registration date and information.
The public workshop will be held as a hybrid event via webcast and an in-person option at the FDA White Oak Campus, Great Room, Bldg. 31, 10903 New Hampshire Ave., Silver Spring, MD 20993. Entrance for the public workshop participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to https://www.fda.gov/about-fda/visitor-information/public-meeting-information and https://www.fda.gov/about-fda/visitor-information/visitor-parking-and-campus-map.
You may submit comments, data, and information as follows. Please note that late, untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of October 19, 2026. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date.
Submit electronic comments in the following way:
Submit written/paper submissions as follows:
Instructions: All submissions received must include Docket No. FDA-2026-N-5479 for “Testosterone Use in Menopausal Women; Public Workshop; Request for Comments.” Received comments, those filed in a timely manner (see ADDRESSES ), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and ( printed page 53418) contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
Lakshmi Kannan, Bldg. 32, Rm. 2333, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-9440, OWHmeetings@fda.hhs.gov.
Menopause represents a significant biological transition for women, marked by cessation of ovarian function and decreased levels of all ovarian steroids, including estrogen and testosterone. Testosterone in women naturally declines with age. Levels in the late 40s are approximately half of those in the early 20s, reaching a nadir in the late 50s, followed by stabilization or modest increases starting in the 60s. The role of declining ovarian testosterone levels in menopausal women and its relationship to medical conditions, such as frailty, depressive symptoms, sleep, sexual function, cognition, and musculoskeletal health, are not well understood. Unlike estrogen-containing products, there are no FDA approved indications for testosterone therapy for menopausal women. Nevertheless, the off-label use of testosterone in women nearing or after menopause has increased over the past decade. Testosterone is currently approved for hypoactive sexual desire disorder (HSDD) in women in Australia, New Zealand, the UK, and South Africa. Beyond HSDD, there are limited data on the treatment effect of testosterone for other clinical uses. While short-term safety data exist for physiologic doses, long-term safety data beyond 24 months are limited, particularly regarding cardiovascular and breast cancer risks. Additionally, challenges exist in testosterone measurement and understanding the relationship between testosterone levels and various clinical outcomes. This public workshop will examine the current scientific evidence and knowledge gaps related to testosterone use in menopausal women to inform future research and potential drug development of testosterone products for menopausal women.
This public workshop will include presentations and session discussions by experts in the fields of women's health, endocrinology, clinical pharmacology, clinical care, and regulators. The patient perspective will also be explored. Sessions will address testosterone physiology throughout a woman's life, navigating measurement challenges, clinical guidelines and practice perspectives, and regulatory considerations for drug approval, including the identification of clinically meaningful endpoints for various indications. Each session will include panel discussions to explore critical research gaps and chart a path forward for testosterone therapy in menopausal women.
Registration: To register for the public workshop, please visit the following website: https://fda.zoomgov.com/webinar/register/WN_vqCrP60TSOGU7fc9uAWUbQ#/registration. Please provide complete contact information for each attendee, including name, title, affiliation, email, and select whether attendance will be virtual or in-person.
Registration is free and based on space availability, with priority given to early registrants. People interested in attending this public workshop in-person must register by September 10, 2026, 11:59 p.m. Eastern Time. Those planning to attend virtually may register up until the date of the meeting. Registrants will receive confirmation when they have been accepted.
If you need special accommodations due to a disability, please contact the FDA Office of Women's Health at OWHmeetings@fda.hhs.gov no later than September 1, 2026.
Streaming Webcast of the Public Workshop: This public workshop will also be webcast, accessible at: https://fda.zoomgov.com/webinar/register/WN_vqCrP60TSOGU7fc9uAWUbQ#/registration.
Notice of this meeting is given pursuant to 21 CFR 10.65.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-16829 Filed 8-17-26; 8:45 am]
BILLING CODE 4164-01-P
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