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# Immunotoxic Potential Draft Guidance Out
- URL: https://www.fdaweb.com/immunotoxic-potential-draft-guidance-out/
- Published: 2020-02-19T12:00:00.000Z
- Updated: 2026-09-14T16:03:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146118

FDA has published a draft guidance, *Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics*, to assist sponsors by supplementing the recommendations on nonclinical immune system assessments provided across a number of International Council for Harmonization and FDA guidances. The [document](https://www.fda.gov/media/135312/download?ref=fdaweb.com) covers the evaluation of functional, histomorphologic, and cellular aspects of the immune system in nonclinical studies for new drugs, therapeutic proteins, and recombinant/plasma-derived blood proteins regulated by CDER and CBER.

Cell and gene therapies, adjuvanted vaccines, and other biologics are not within the guidance’s scope, although FDA says that some of the principles in it may be applicable to those product types.

The guidance replaces a withdrawn 10/2002 guidance.

Contents of the draft are Introduction, Background, Assessing the Potential for Products to Reduce the Activity of the Immune System, Assessing the Potential for Products to Increase Activity of the Immune System, and Developmental and Juvenile Studies.