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Immunotoxicology Evaluation of Investigational New Drugs November 2002

Docket Number:
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance makes recommendations to sponsors of investigational new drugs (INDs) on (1) the parameters that should be routinely assessed in toxicology studies to determine effects of a drug on immune function, (2) when additional immunotoxicity studies should be conducted, and (3) when additional mechanistic information could help characterize the significance of a given drug’s effect on the immune system. This guidance is intended for drug products and does not apply to biological products.

Submit Comments

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:

Dockets Management
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-2001-D-0041.

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