FDA Wants Your Thoughts on Men's Testosterone Therapy Treatments
Published Date: 12/11/2025
Notice
Summary
The FDA wants to hear from men, doctors, and anyone interested about testosterone replacement therapy. They’re gathering info to help decide if and how this treatment should be used or changed. If you want to share your thoughts, make sure to send them by February 9, 2026—this could shape future rules and affect costs or access to therapy.
Analyzed Economic Effects
3 provisions identified: 1 benefits, 0 costs, 2 mixed.
Public comment window — deadline Feb 9, 2026
The FDA is asking the public to submit information about testosterone replacement therapy by February 9, 2026. You can send electronic comments at https://www.regulations.gov (Docket No. FDA-2025-N-6743) until 11:59 p.m. Eastern Time on that date; paper comments received by mail/hand delivery will also be considered timely if received on or before February 9, 2026.
Possible updates to TRT labeling and indications
FDA stated that any potential updates to testosterone labeling, including revisions to approved indications, would go through the Agency's standard scientific review process. Changes to labeling or approved uses could affect who is eligible for testosterone therapy and how it is prescribed, which may in turn affect access or cost for people receiving treatment.
Continued oversight of prescription and OTC products
FDA said it will continue robust oversight of both prescription testosterone therapies and over-the-counter supplements. That oversight aims to protect patient safety (for example, around cardiovascular risk, prostate health, fertility, and potential for abuse) and may affect the availability, marketing, or labeling of some products.
Your PRIA Score
Personalized for You
How does this regulation affect your finances?
Sign up for a PRIA Policy Scan to see your personalized alignment score for this federal register document and every other regulation we track. We analyze your financial profile against policy provisions to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-10321 — Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Safety and Effectiveness of MFLUSIVA (Influenza Vaccine, mRNA) Manufactured by Moderna TX Inc.
The FDA is holding a public meeting on June 18, 2026, to talk about the safety and effectiveness of MFLUSIVA, a new flu vaccine made by Moderna. Anyone can watch online and share their thoughts before June 17. This is a big deal for people who get flu shots and could affect how this vaccine is used and approved.
2026-10295 — M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP); International Council for Harmonisation; Guidance for Industry; Availability
The FDA just released a new, easy-to-use digital guide called M11 CeSHarP to help everyone involved in clinical trials share and review study plans faster and clearer. This affects drug companies, researchers, and regulators worldwide by setting a global standard for how trial info is written and shared electronically. The new rules kick in now, aiming to save time and reduce confusion, with no direct cost but big efficiency gains.
2026-10277 — Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
The FDA just released new draft guides to help drug makers design studies proving their generic drugs work like the originals. If you’re in the drug business, now’s your chance to share feedback by July 21, 2026, before these guides become final. These updates aim to speed up drug approvals, potentially saving time and money for companies and patients alike!
2026-10284 — Protein Efficiency Ratio Rat Bioassay Studies To Demonstrate That a New Infant Formula Supports the Quality Factor of Sufficient Biological Quality of Protein; Guidance for Industry; Availability
The FDA just released new guidance to help baby formula makers prove their products have good-quality protein using special rat studies. This update affects formula manufacturers and labs, making it easier and clearer to show their formulas meet nutrition standards. The guidance is effective now, helping companies avoid costly mistakes and speed up getting new formulas to market.
2026-10268 — Notice of Decision Not To Designate Hepatitis Delta Virus Diseases as an Addition to the Current List of Tropical Diseases in the Federal Food, Drug, and Cosmetic Act
The FDA decided not to add Hepatitis Delta Virus (HDV) to the list of tropical diseases because it doesn’t fully meet the rules about market size and who it affects. This means drug makers won’t get special priority review vouchers for HDV treatments right now. People working on HDV drugs should keep an eye out for future updates but won’t see changes or new incentives immediately.
2026-10190 — Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Patent Term Restoration; Due Diligence Petitions; Filing, Format, and Content of Petitions
The FDA is updating how companies ask for extra patent time when their new drugs or devices take a while to get approved. This affects drug and medical device makers who want to protect their inventions longer. Comments on these changes are open until June 22, 2026, and the update aims to keep the process clear without adding extra costs or delays.
Previous / Next Documents
Previous: 2025-22465 — Request for Comments on the Renewal of a Previously Approved Information Collection: Application for Conveyance of Port Facility Property
The Maritime Administration wants to keep collecting info from people applying to take over port property for redevelopment. They’re asking for your thoughts on how this process works and if it’s fair and clear. If you’re involved in port projects or just curious, speak up by February 9, 2026—this helps keep port plans smart and smooth without extra hassle or cost.
Next: 2025-22467 — Self-Regulatory Organizations; Investors Exchange LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the Fee Schedule Pursuant to IEX Rules 15.110(a) and (c) To Delete Obsolete Language
Investors Exchange (IEX) is cleaning up its fee schedule by removing old, outdated language about fees that started on October 1, 2025. This change won’t affect any current fees or costs but makes the rules clearer for everyone using the exchange. The update took effect right away on December 2, 2025, so no waiting around!