Testosteronology Society Submits Expert Response to FDA on Testosterone Therapy

The global professional organization aims to elevate clinical standards and reduce variability in care for testosterone and androgen therapy.

Published on Feb. 6, 2026

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The Testosteronology Society, a global professional organization focused on advancing safe and evidence-based testosterone replacement therapy, has formally submitted a comprehensive expert response to the U.S. Food and Drug Administration's Request for Information on Testosterone Replacement Therapy for Men. The submission reflects the real-world clinical experience and scientific expertise of the society's member clinicians who specialize in testosterone and androgen care.

Why it matters

The FDA's request for input signals a federal reassessment of long-standing policies related to testosterone therapy, including safety warnings, diagnostic criteria, approved indications, and regulatory classification. The Testosteronology Society's response aims to ensure that evidence, ethics, and real-world expertise guide the future of testosterone care in the United States.

The details

The Testosteronology Society's submission addresses the FDA's questions across multiple domains, including cardiovascular and metabolic outcomes, thromboembolic risk, musculoskeletal health, mental health considerations, patient selection, timing and duration of therapy, formulation and dosing variables, provider and patient education, and future research priorities. The response also engages broader scientific considerations related to diagnostic thresholds for age-related androgen deficiency, barriers to research and access, and opportunities to modernize data collection and evidence generation.

  • The FDA issued its Request for Information in December 2025.
  • The Testosteronology Society submitted its expert response in February 2026.

The players

Testosteronology Society

A global professional organization dedicated to advancing safe, ethical, and evidence-based testosterone replacement therapy and androgen-focused care through clinician education, certification, standards, and advocacy.

Dr. Thomas O'Connor

Founder and Chief of the Testosteronology Society.

Omar Hajmousa

Director of Education and Strategy for the Testosteronology Society.

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What they’re saying

“This submission reflects the collective expertise of clinicians practicing at the highest level of androgen care.”

— Dr. Thomas O'Connor, Founder and Chief of the Testosteronology Society (PRNewswire-PRWeb)

“This was not a theoretical exercise. Our response was built from clinical realities, data literacy, and a commitment to advancing standards that protect patients while supporting appropriate access to care.”

— Omar Hajmousa, Director of Education and Strategy for the Testosteronology Society (PRNewswire-PRWeb)

What’s next

The Testosteronology Society will publish additional information, including the FDA's response to its submission, as it becomes available. As the regulatory landscape evolves, the organization remains committed to engaging constructively with regulators and stakeholders to help shape a modern, evidence-based framework for testosterone therapy in the United States.

The takeaway

The Testosteronology Society's expert response to the FDA underscores the importance of elevating real-world clinical expertise and scientific evidence in the ongoing national discussion surrounding the appropriate use and regulation of testosterone replacement therapy.