FDA Issues Guidance on Evaluation of Drug Toxicity

On Sept. 8, 2015, FDA issued recommendations to sponsors of investigational new drug applications, new drug applications, and biologics license applications regarding nonclinical studies performed to identify potential endocrine-related toxicity. The guidance describes how endocrine-related toxicity is assessed and identifies when additional studies should be considered. The guidance is specific to nonclinical testing “designed to assess the potential for a drug to cause endocrine effects that are unintentional and adverse,” and does not provide guidance relating to “development of drugs that are intended to interfere with the endocrine system to prevent or treat a particular disease or condition, and it does not provide detailed recommendations regarding clinical studies to investigate adverse endocrine-related activity.” The guidance does not cover environmental assessment issues.