The 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, announces the submission of its comprehensive expert response to the U.S. Food and Drug Administration's Request for Information on Testosterone Replacement Therapy for Men.
FORT LAUDERDALE, Fla., Feb. 6, 2026 /PRNewswire-PRWeb/ -- The Testosteronology Society™ today announced that it has formally submitted a comprehensive expert response to the Food and Drug Administration Expert Panel on Testosterone Replacement Therapy for Men, following the agency's December 2025 Request for Information seeking clinical, scientific, and regulatory input on testosterone therapy.
The FDA's Request for Information represents a significant moment for the field of androgen-based medicine, signaling a federal reassessment of long-standing policies related to testosterone therapy, including safety warnings, diagnostic criteria, approved indications, and regulatory classification. The Testosteronology Society™ responded with a detailed submission reflecting the real-world clinical experience and scientific expertise of clinicians who specialize in testosterone and androgen care.
The Testosteronology Society™ 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 Testosteronology Society™ was established to advance excellence in testosterone replacement therapy, men's and women's hormone health, and clinical androgen care through structured education, certification, collaboration, and professional standards. Members of the Testosteronology Society™ include clinicians who manage complex hormone cases and longitudinal patient outcomes, positioning the organization as a critical professional voice in national discussions surrounding modern testosterone therapy.
"This submission reflects the collective expertise of clinicians practicing at the highest level of androgen care," said Dr. Thomas O'Connor, Founder and Chief of the Testosteronology Society™. "When federal regulators ask for expert guidance, it is essential that policy decisions are informed by both rigorous science and real-world clinical experience."
The FDA's Request for Information also explored opportunities for collaboration among healthcare providers, researchers, patients, and industry stakeholders to further define therapeutic uses of testosterone therapy and generate higher-quality evidence supporting safety and efficacy. The Testosteronology Society™ response emphasized the importance of standardized education, advanced clinical training, and professional accountability as foundational elements of responsible expansion.
According to Omar Hajmousa, PharmD, Director of Education and Strategy for the Testosteronology Society™, the submission reflects a deliberate effort to elevate the national conversation surrounding testosterone therapy. "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."
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 Testosteronology Society™ remains committed to engaging constructively with regulators and stakeholders to help shape a modern, evidence-based framework for testosterone therapy in the United States.
Clinicians interested in professional leadership, advanced education, certification, and regulatory advocacy related to testosterone and androgen care are encouraged to engage with the Testosteronology Society™.
About the Testosteronology Society™
The Testosteronology Society™ is a global professional organization dedicated to advancing safe, ethical, and evidence-based care for men and women receiving testosterone and other androgens. Through structured education, certification, professional collaboration, and advocacy, the Testosteronology Society™ works to elevate clinical standards, reduce variability in care, and support healthcare professionals who specialize in hormone-based medicine.
To further this mission, the Testosteronology Society™ launched the Testosteronology® Health Portal, a comprehensive digital membership platform designed to address the growing worldwide need for higher-quality hormone education and patient engagement. The Testosteronology® Health Portal provides accessible, evidence-based educational resources that help individuals better understand testosterone, androgens, and hormone-related health conditions, empowering them to become knowledgeable and actively involved participants in their own healthcare.
The Testosteronology® Health Portal serves as a global platform through which Certified Testosteronologists from the Testosteronology Society™ contribute their collective clinical knowledge and real-world experience, providing the public with trusted education, guidance, and resources that empower individuals to become informed and actively involved in their own healthcare decisions. By combining clinician-led education with patient-centered learning, the Testosteronology Society™ and the Testosteronology Health Portal are advancing a global standard of informed care, shared decision-making, and improved health outcomes in testosterone and hormone therapy.
For more information, visit https://testosteronologysociety.com and https://testosteronology.com.
Media Contact
Dr. Thomas O'Connor, Testosteronology Society, 1 860 904-6779, [email protected], https://testosteronologysociety.com
SOURCE Testosteronology Society
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