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In this section: Search for FDA Guidance Documents

GUIDANCE DOCUMENT

Carcinogenicity Study Protocol Submissions May 2002

Final

Docket Number:: FDA-2000-D-1405
Issued by:: Guidance Issuing Office

Center for Drug Evaluation and Research

This guidance is intended to inform sponsors of the types of information the Center for Drug Evaluation and Research (CDER) relies on when evaluating protocols for animal carcinogenicity studies.

Submit Comments

Submit Comments Online

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-2000-D-1405.

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