Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics; Draft Guidance for Industry; Availability

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled "Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics." This guidance expands upon, consolidates, and supplements the recommendations on nonclinical immune system assessments provided across multiple guidance documents, most notably the International Conference on Harmonization (ICH) guidance for industry "S8 Immunotoxicity Studies for Human Pharmaceuticals." The topics covered include various aspects of immune suppression, modulation, and stimulation. This guidance replaces the withdrawn guidance entitled "Immunotoxicology Evaluation of Investigational New Drugs."