The U.S. Food and Drug Administration has published for comment its draft Guidance for Industry Endocrine Disruption Potential of Drugs: Nonclinical Evaluation. According to the FDA, “This draft guidance provides recommendations to sponsors of investigational new drug applications, new drug applications, and biologics license applications regulated by the Center for Drug Evaluation and Research (CDER) regarding nonclinical studies intended to identify the potential for a drug to disrupt the endocrine system. The guidance discusses factors that should be considered when determining the nature and extent of nonclinical studies necessary to characterize potential endocrine disruptor properties of drugs.” This FDA guidance on endocrine disruption testing does not mention EPA’s EDSP program. The FDA asks for comments on this draft guidance by November 19, 2013.
Click here to read the FDA’s draft Guidance.