Docket Number:
FDA-2019-D-5607
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

The purpose of this guidance is to assist sponsors in their nonclinical evaluation of the immunotoxic potential of drugs and biologics by supplementing the recommendations on nonclinical immune system assessments provided across the following guidance documents:

• International Council for Harmonisation (ICH) guidances for industry:

– S8 Immunotoxicity Studies for Human Pharmaceuticals (April 2006)

– M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (January 2010)

– S6(R1) Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals (May 2012)

– S5(R3) Detection of Toxicity to Reproduction for Human Pharmaceuticals (November 2017)

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All written comments should be identified with this document's docket number: FDA-2019-D-5607.