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GUIDANCE DOCUMENT

S8 Immunotoxicity Studies for Human Pharmaceuticals April 2006

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2005-D-0398
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center 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.

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All written comments should be identified with this document's docket number: FDA-2005-D-0398.

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