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.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.