Business · 03/01/2018Updated: 10/17/2026 · 1 min read

FDA Releases Draft Guidance for Treating Male Hypogonadotropic Hypogonadism with Testosterone Replacement Therapy

The FDA has published a draft guidance outlining key considerations for clinical trials to establish effectiveness of drugs treating male hypogonadotropic hypogonadism associated with obesity and other non-intrinsic conditions, consistent with previous advisory committee recommendations.