Immunotoxicology Evaluation of Investigational New Drugs

This guidance makes recommendations to sponsors of investigational new drugs (INDs) on (1) the parameters that should be routinely assessed in toxicology studies to determine effects of a drug on immune function, (2) when additional immunotoxicity studies should be conducted, and (3) when additional

Source: FDA Center for Drug Evaluation and Research - What's New - February 27, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news