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GUIDANCE DOCUMENT

S9 Nonclinical Evaluation for Anticancer Pharmaceuticals March 2010

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2009-D-0006
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

The purpose of this guidance is to provide information to assist in the design of an appropriate program of nonclinical studies for the development of anticancer pharmaceuticals. The guidance provides recommendations for nonclinical evaluations to support the development of anticancer pharmaceuticals in clinical trials for the treatment of patients with advanced disease and limited therapeutic options.

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2009-D-0006.

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