Guidance for Industry on Immunotoxicology Evaluation of Investigational New Drugs; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Immunotoxicology Evaluation of Investigational New Drugs." This guidance provides recommendations for sponsors of investigational new drugs (INDs) on what parameters to routinely assess in toxicology studies to determine effects on immune function, when to conduct additional immunotoxicity studies, and when additional mechanistic information could better characterize a given effect on the immune system.