FDA Review of Testosterone for Menopausal Women: How to Comment
Medically reviewed by Dr. Michael Teplitsky, MD Last reviewed 2026-10-12
What the federal docket covers and how the public can file comments before October 19, 2026
FDA is taking public comments on testosterone use in menopausal women until 11:59 p.m. ET on October 19, 2026, after a September 17, 2026 workshop on the evidence and knowledge gaps. A public workshop and a comment docket collect information; neither is a drug approval or a recommendation about treatment.
The Food and Drug Administration (FDA) Office of Women's Health (OWH) and the Center for Drug Evaluation and Research (CDER) held a public workshop on testosterone use in menopausal women on September 17, 2026. FDA opened docket FDA-2026-N-5479 on Regulations.gov to collect comments on risks and benefits. To be assured of consideration, comments must be received no later than 11:59 p.m. Eastern Time (ET) on October 19, 2026.
FDA's stated background: menopause is marked by a significant decline in ovarian hormones, including testosterone. Off-label use of testosterone therapy in menopausal women is growing, FDA says. Critical knowledge gaps remain.
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See Opt Health's women's program →The docket is open for 60 days. The workshop notice carries Federal Register document number 2026-16829. A public workshop and a comment docket collect information; neither is a drug approval or a recommendation about treatment.
What FDA Is Reviewing
The workshop was designed to examine the current scientific evidence and critical knowledge gaps related to testosterone use in menopausal women. FDA's OWH and CDER held it as a public hybrid workshop titled "Testosterone Use in Menopausal Women" on September 17, 2026, from 9:00 a.m. to 4:30 p.m. ET, at the FDA White Oak Campus, Building 31, in Silver Spring, Maryland, and online via YouTube.
Evidence Gaps FDA Has Named
FDA names the role of testosterone therapy in sexual function, cognition, mood and musculoskeletal health as a knowledge gap. It also names challenges in measuring and interpreting testosterone levels, and the absence of long-term safety data, especially regarding cardiovascular and breast cancer risks.
FDA's stated purpose was to help inform future research and potential drug development. Registration is now closed. FDA's event page links to the broadcast, the agenda and the speaker biographies: FDA public meeting page: Testosterone Use in Menopausal Women.
How to Submit a Comment
FDA's Federal Register notice announcing the workshop (document number 2026-16829) is filed under docket FDA-2026-N-5479 on Regulations.gov. FDA opened the docket to receive broad public comments on the risks and benefits of testosterone use in menopausal women.
Filing Before the Deadline
The docket is open for public comments for 60 days. To be assured of consideration, a comment must be received no later than 11:59 p.m. ET on October 19, 2026. The Federal Register notice (public inspection) for the workshop is available on federalregister.gov.
FDA directs readers to Regulations.gov for complete submission requirements. To comment, search for docket number FDA-2026-N-5479 on Regulations.gov and follow its submission requirements. The workshop agenda and biographies for speakers and moderators are posted as a PDF. Questions about the event can be sent to owhmeetings@fda.hhs.gov.
What a Workshop and Docket Do and Do Not Decide
A public workshop and a comment docket collect information. Neither is a drug approval or a recommendation about treatment. FDA's stated purpose for the workshop was to help inform future research and potential drug development.
A reader with questions about their own hormones should talk to a licensed clinician.
Why Measurement Is on the List
FDA names challenges in measuring and interpreting testosterone levels among its knowledge gaps. For background reading, see our pages on free testosterone, SHBG and testosterone by age.
How to test testosterone at home
You don't need a lab appointment to check your own testosterone — a few at-home kits mail you a collection kit and return physician-reviewed results online within days:
Prefer to order direct? The Everlywell Testosterone Test uses a CLIA-certified lab, physician-reviewed results, and prepaid return shipping.
Frequently Asked Questions
When is the deadline to comment on the FDA testosterone docket?
Comments on docket FDA-2026-N-5479 must be received no later than 11:59 p.m. Eastern Time on October 19, 2026, to be assured of consideration. The docket is open for public comments for 60 days. FDA directs readers to Regulations.gov for complete submission requirements.
What is docket FDA-2026-N-5479?
Docket FDA-2026-N-5479 is the docket on Regulations.gov where FDA is accepting broad public comments on the risks and benefits of testosterone use in menopausal women. The Federal Register notice announcing the workshop, document number 2026-16829, is filed under this docket.
Did FDA decide anything about testosterone for menopausal women?
FDA has not stated a decision. It held the September 17, 2026 workshop to examine the current scientific evidence and critical knowledge gaps, to help inform future research and potential drug development.
What safety questions is FDA asking about?
FDA names the absence of long-term safety data, especially regarding cardiovascular and breast cancer risks. It also lists open questions about the role of testosterone therapy in sexual function, cognition, mood and musculoskeletal health, and about measuring and interpreting testosterone levels.
Where can I watch the workshop?
FDA broadcast the September 17, 2026 workshop live on YouTube, and the FDA public meeting page: Testosterone Use in Menopausal Women links to it. The page also posts the agenda and biographies for speakers and moderators as a PDF.
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