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# Guide on Nonclinical Immunotoxic Evaluations
- URL: https://www.fdaweb.com/guide-on-nonclinical-immunotoxic-evaluations-2/
- Published: 2023-06-05T12:00:00.000Z
- Updated: 2026-09-14T18:36:12.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5154613

FDA has released a final guidance entitled “Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals.” Focused on nonclinical safety evaluations by sponsors, it defines immunotoxicity as “any adverse unintended immunosuppression or stimulation, which can be the result of off-target effects or exaggerated pharmacology of pharmaceuticals that are intended to act as immunomodulators.” To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-06-05/pdf/2023-11898.pdf?ref=fdaweb.com).