1. Home
  2. For Consumers
  3. Women's Health
  4. OWH Education and Training
  5. Women's Health Events
  6. FDA Public Meeting: Testosterone Use In Menopausal Women - 09/17/2026
  1. Women's Health Events

Meeting | Mixed

Event Title
FDA Public Meeting: Testosterone Use In Menopausal Women
September 17, 2026

Date:
September 17, 2026
Time:
9:00 a.m. - 4:30 p.m. ET
Location:
Event Location
Attend In Person or Online
Virtual: Via Zoom
In Person: FDA White Oak Campus

10903 New Hampshire Ave
Building 31, Room 1503
Silver Spring, MD 20993
United States


Image
A dark navy blue promotional graphic with the FDA logo in the upper right corner. A teal banner in the upper left reads "Join us for a Public Workshop." Bold white text reads "FDA Office of Women's Health (OWH) and Center for Drug Evaluation and Research (CDER) Present." The workshop title, "Testosterone Use in Menopausal Women," is displayed in large teal bold text. Below, event details read: "September 17, 2026 | 9 AM – 4:30 PM ET, Hybrid Event (In-person and Virtual)."

Join the FDA Office of Women’s Health (OWH) and Center for Drug Evaluation and Research (CDER) for a public hybrid workshop on Testosterone Use in Menopausal Women.

Background:  

Menopause is marked by a significant decline in ovarian hormones, including testosterone. Despite growing off-label use of testosterone therapy in menopausal women, critical knowledge gaps remain. These gaps include the role of testosterone therapy in sexual function, cognition, mood, and musculoskeletal health; challenges in measuring and interpreting testosterone levels; and the absence of long-term safety data, especially regarding cardiovascular and breast cancer risks.

The purpose of the 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 in this area.  

The workshop will be held in a hybrid format accessible both in-person at the FDA White Oak Campus (Great Room) and virtually. Registration is required for in-person and virtual attendance. The workshop will take place in the Great Room, Building 31, FDA White Oak Campus at 10903 New Hampshire Avenue, Silver Spring, MD.

The Federal Register Notice (FRN) announcing this workshop can be found at Regulations.gov under docket number FDA-2026-N-5479. The FDA is opening a docket to allow for submission of broad, public comments on the risks and benefits related to testosterone use in menopausal women. The docket will be open for public comments for 60 days. To be assured of consideration, comments must be received no later than 11:59 p.m. Eastern Time (ET) on October 19, 2026. Visit Regulations.gov for complete details on submission requirements for comments. 

This webpage will be updated as meeting materials are developed.  

Virtual Attendance Information 

This workshop will be hybrid. The Zoom link will be provided to all registered attendees via email before the workshop.

Important Registration Notice

IN-PERSON REGISTRATION CLOSES ON SEPTEMBER 10 OR ONCE MAXIMUM CAPACITY IS REACHED. Virtual registration will remain open after this date. If you plan to attend in person, please complete your registration as early as possible to secure your spot. All in-person attendees are required to bring a printed or digital copy of their registration confirmation to the meeting for check-in.

Visiting the FDA Campus

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 Public Meeting Information, Getting to the FDA, and Visitor Parking and Campus Map.

Food & Drink 

Refreshments and boxed lunches will be available for purchase on the day of the workshop. Electronic payment is preferred. Attendees may bring their own food and drink; however, the FDA cannot guarantee the use of a refrigerator or microwave. Restaurants near the FDA White Oak campus are available, but meeting attendees should consider the amount of time needed to return to campus and go through security screening.

Accessibility  

The FDA will make every effort to accommodate persons with physical disabilities or special needs at public meetings. If you require accommodations due to a disability, email owhmeetings@fda.hhs.gov at least 14 days before a public meeting. The FDA White Oak campus and FDA shuttle are generally accessible to people with physical disabilities.

Contact

For questions regarding this event, please contact owhmeetings@fda.hhs.gov. 

Media Inquiries

Please direct all media inquiries to the HHS Office of the Assistant Secretary for Public Affairs (ASPA): https://hhscewp.my.site.com/ASPAPublic/s/request-for-comment.

Back to Top