Upcoming FDA Expert Panel on Testosterone Replacement Therapy for Men

madman · Monday at 4:54 PM

4.5K views · 49 reactions | Men’s health will be in the spotlight at our next expert panel on Wednesday, December 10 from 1-3pm. Register to attend in person or watch online: https://www.fda.gov/patients/fda-expert-panels/fda-expert-panel-testost

Men’s health will be in the spotlight at our next expert panel on Wednesday, December 10 from 1-3pm. Register to attend in person or watch online:...

www.facebook.com

madman · Monday at 9:51 PM

Thread 'FDA issues class-wide labeling changes for testosterone products'

Feb 28, 2025

FDA issues class-wide labeling changes for testosterone products

www.fda.gov

[2/28/2025] Today, FDA informed sponsors of testosterone products about new labeling changes following the agency’s review of the findings from the Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy Response in Hypogonadal Men (TRAVERSE) clinical trial External Link Disclaimer and the results from required postmarket ambulatory blood pressure (ABPM) studies.

Led by the...

Nelson Vergel · Tuesday at 1:47 AM

madman said:
@Nelson Vergel

We need you here!

FDA Expert Panel on Testosterone Replacement Therapy for Men

FDA Expert Panel on Testosterone Replacement Therapy for Men

www.fda.gov

View attachment 54158

Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31, Great Room, Silver Spring, MD 20993-0002. There will be limited seating for the public.

Registration: Registration is only required for in-person listen-in attendance. Space is limited. Please plan to arrive at least 30 minutes prior to the start time to be checked in.

How to Virtually Attend: This FDA Expert Panel will be live streamed over the FDA’s YouTube channel External Link Disclaimer.

FDA plans to provide a free of charge live webcast of the Expert Panel. If there are instances where the webcast transmission is not successful, staff will work to re-establish the transmission as soon as possible.

Thanks for letting me know. Too bad I would have to fly from Portugal. Hopefully, we can see progress in the labeling.

Nelson Vergel · Tuesday at 5:36 PM

One of my comments:

The current labeling for injectable testosterone cypionate and enanthate, which recommends dosing intervals of 50–400 mg every two to four weeks, warrants reconsideration in light of contemporary pharmacokinetic and clinical evidence. Emerging data suggest that more frequent dosing regimens, specifically 100–150 mg administered weekly, produce more stable serum testosterone concentrations and may reduce the incidence of adverse effects, particularly erythrocytosis and HDL cholesterol reduction. The present labeling may contribute to suboptimal dosing practices and clinical outcomes due to variability in provider familiarity with testosterone replacement therapy pharmacology. We respectfully request that the panel consider this topic during the roundtable discussion.

As a long-standing advocate and author with extensive experience in testosterone replacement therapy education and community engagement, I have observed the clinical implications of current labeling practices firsthand.

Respectfully submitted,

Nelson Vergel

madman · Tuesday at 5:40 PM

Nelson Vergel said:
One of my comments:

The current labeling for injectable testosterone cypionate and enanthate, which recommends dosing intervals of 50–400 mg every two to four weeks, warrants reconsideration in light of contemporary pharmacokinetic and clinical evidence. Emerging data suggest that more frequent dosing regimens, specifically 100–150 mg administered weekly, produce more stable serum testosterone concentrations and may reduce the incidence of adverse effects, particularly erythrocytosis and HDL cholesterol reduction. The present labeling may contribute to suboptimal dosing practices and clinical outcomes due to variability in provider familiarity with testosterone replacement therapy pharmacology. We respectfully request that the panel consider this topic during the roundtable discussion.

As a long-standing advocate and author with extensive experience in testosterone replacement therapy education and community engagement, I have observed the clinical implications of current labeling practices firsthand.

Respectfully submitted,

Nelson Vergel