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GUIDANCE DOCUMENT

Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics Guidance for Industry February 2020

Draft Level 1 Revised Guidance

Not for implementation. Contains non-binding recommendations.

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)


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

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