Draft Guidance for Industry on Immunotoxicology Evaluation of Investigational New Drugs; Availability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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Immunotoxicology Evaluation of Investigational New Drugs." This draft guidance provides recommendations for sponsors of investigational new drugs (INDs) on the parameters that should be routinely assessed in toxicology studies to determine effects on immune function, when additional specific immunotoxicity studies should be conducted, and when additional mechanistic information could better evaluate a given effect on the immune system.