The sponsors of testosterone replacement therapies may have to conduct additional studies to assess both the potential cardiovascular risk of these products and to show that they actually benefit the primary population using the drugs, according to FDA briefing documents for an upcoming advisory committee meeting.
Testosterone Makers May Have To Do CV Risk Studies, Prove Benefit For ‘Low T’ Use
FDA says current epidemiological studies do not provide “convincing evidence” the products are either particularly helpful or harmful for treatment of aging men with low testosterone.