FDA ponders testosterone therapy for menopausal women workshop
Published Date: 8/18/2026
Notice
Summary
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.
No Economic Impacts Identified for this Document
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-16296, Substances Generally Recognized as Safe
The Food and Drug Administration (FDA or we) is proposing to require the submission of generally recognized as safe (GRAS) notices for the use of a human or animal food substance purported to be GRAS under the conditions of its intended use under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
2026-14073, Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
The FDA wants to make it easier for drug makers who work in several locations to register as one company instead of many. They’re also updating rules for foreign drug companies to match new laws about handling health threats. If you’re in drug manufacturing, get ready to comment by September 11, 2026, and keep an eye on possible paperwork changes that could affect your business.
2026-13047, Establishment Registration and Product Listing for Tobacco Products
The FDA wants to make sure all tobacco product makers, both in the U.S. and abroad, register their businesses and list their products. This new rule closes a big gap by including foreign companies, helping the FDA keep better track of tobacco products for public health. Comments on this proposal are open until September 14, 2026, so affected businesses should get ready to update their info and possibly face new costs.
2026-16728, Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended as an Aid for Detection of Bladder Cancer
The Food and Drug Administration (FDA) is proposing to reclassify diagnostic endoscopic light source systems (product code OAY), which are postamendments class III devices, from class III (premarket approval) into class II (special controls), subject to premarket notification. FDA is also proposing a new device classification regulation with the name "Cystoscopic system intended as an aid for detection of bladder cancer," along with special controls that FDA believes are necessary to provide a reasonable assurance of the safety and effectiveness of these devices.
2026-16712, Agency Information Collection Activities; Proposed Collection; Comment Request; Imports and Electronic Import Entries
The FDA wants your thoughts on how they collect info about imports and electronic import entries. If you’re involved in importing goods, this could affect you! They’re asking for comments by October 16, 2026, to help improve the process without adding extra costs or hassle.
2026-16727, Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final order reclassifying in situ hybridization (ISH) test systems indicated for use with a corresponding approved oncology therapeutic product (product codes NYQ, MVD, OWE, and PNK), all postamendments class III (premarket approval) devices, into class II (special controls), subject to premarket notification. FDA is also establishing a new device classification regulation, along with the special controls that are necessary to provide a reasonable assurance of safety and effectiveness of this device type.
Previous / Next Documents
Previous: 2026-16827, Agency Information Collection Activities; Proposed Collection; Comment Request; Extension
The Federal Trade Commission (FTC or Commission) requests that the Office of Management and Budget (OMB) extend for three years the current Paperwork Reduction Act (PRA) clearance for its Trade Regulation Rule on Disclosure Requirements and Prohibitions Concerning Franchising (Franchise Rule or Rule). The current clearance expires on August 31, 2026.
Next: 2026-16830, Self-Regulatory Organizations; NYSE American LLC; Notice of Filing of Amendment No. 4 and Order Granting Accelerated Approval of a Proposed Rule Change, as Modified by Amendment No. 4, To Amend Section 1003 of the NYSE American Company Guide