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GUIDANCE DOCUMENT

Cancer Drug and Biological Products - Clinical Data in Marketing Applications October 2001

Download the Final Guidance Document
Final
Docket Number:
FDA-2000-D-0100
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This document provides recommendations for sponsors on data collection for cancer clinical trials submitted to FDA to support marketing claims in new drug applications (NDAs), biologics license applications (BLAs), or supplemental applications for new indications. The data collected should be sufficient to evaluate the safety and effectiveness of the treatment but need not include other data. This guidance is also intended for private investigators, cooperative cancer groups, contract research organizations, and others designing and conducting studies that later can be used in a marketing application for an anticancer drug or biological product.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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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-0100.

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