Zdrowie i gospodarka · 17/07/2015

Testicular Toxicity: Evaluation During Drug Development; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Testicular Toxicity: Evaluation During Drug Development." The draft guidance addresses nonclinical findings that may raise concerns of a drug- related adverse effect on the testes, clinical monitoring of adverse testicular effects early in clinical development, and the design and conduct of a safety clinical trial assessing drug-related testicular toxicity. The draft guidance is intended to assist sponsors developing drugs to identify nonclinical signals of testicular toxicity and to evaluate the potential for such toxicity in humans.