- Docket Number:
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Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter for Biologics Evaluation and Research
The objectives of this guidance are to provide (1) recommendations on nonclinical testing approaches to identify compounds that have the potential to be immunotoxic and (2) guidance on a weight-of-evidence decisionmaking approach for immunotoxicity testing. Immunotoxicity is, for the purpose of this guidance, defined as unintended immunosuppression or enhancement. Drug-induced hypersensitivity and autoimmunity are excluded.
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:
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-2005-D-0398.