Hypogonadism Trial Designs: FDA Panel Favors Symptom Assessments, Fertility Measures
US advisory committee rejects Repros Therapeutics' proposal for an obesity-related hypogonadism study in which efficacy is based upon testosterone levels and sperm concentrations.
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US FDA's New Hypogonadism Guidance Focuses On Non-Testosterone Products
Draft is intended to inform development of non-testosterone products such as aromatase inhibitors or estrogen receptor agonists.
CHMP Readies ‘Outstanding Issues’ Lists For Products Nearing EU Review End
Baxter, Ariad, Diurnal. Kyowa Kirin and AB Science are among the companies that will likely shortly find out what remaining concerns the European Medicines Agency’s key advisory panel, the CHMP, has regarding products of theirs that are under review.
Real World Evidence: ‘Hot Topic’ At US FDA, But Not On Front Burner
Officials are enthusiastic about the possibility of ‘real world evidence’ supporting the regulatory process – but are also eager to tamp down expectations (or fears) that it will make a big difference any time soon.