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# Nonclinical Evaluation of Immunotoxicity Guide
- URL: https://www.fdaweb.com/nonclinical-evaluation-of-immunotoxicity-guide/
- Published: 2020-02-20T12:00:00.000Z
- Updated: 2026-09-14T16:03:50.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5146131

*Federal Register* notice: FDA has made available a draft guidance entitled “Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics.” The document expands upon recommendations on nonclinical immune system assessments provided in multiple other guidances, such as the International Conference on Harmonization’s “S8 Immunotoxicity Studies for Human Pharmaceuticals.” Topics covered include immune suppression, modulation, and stimulation. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2020-02-20/pdf/2020-03426.pdf?ref=fdaweb.com).