FDA Testosterone Therapy Updates & the Future of Men’s Health

[madman]

In this episode of AUANews Inside Tract, host Dr. Mark Edney speaks with Dr. Helen Burnie about the FDA’s proposed updates to testosterone therapy labeling and what they could mean for urologists, patients, and the broader field of men’s health. The discussion explores new evidence on cardiovascular safety, prostate cancer, BPH, and appropriate patient selection, while emphasizing the importance of evidence-based prescribing, shared decision-making, fertility counseling, and ongoing monitoring.

 

[madman]

Thread 'U.S. Department of Health and Human Services through the FDA Requested Updates to Testosterone Therapy Product Labels'

Jun 19, 2026

https://www.hhs.gov/press-room/fda-requests-updates-testosterone-therapy-labeling.html

The U.S. Department of Health and Human Services, through the U.S. Food and Drug Administration (FDA), announced today that it is requesting updates to the prescribing information for testosterone replacement therapy products following a comprehensive review of new clinical data and existing scientific evidence.




The proposed changes would:

• Remove the limitation of use stating that the safety and effectiveness of testosterone replacement therapy in men with age-related...

• madman
• hypogonadism; testosterone; fda; health
• Replies: 3
• Forum: Testosterone and Men's Health Articles