U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products
  1. Regulatory Information

GUIDANCE DOCUMENT

FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products December 1998

Final

FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products

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

This document provides guidance to sponsors planning to file applications for new uses of marketed drug and biological products for the treatment of cancer. This guidance for industry is part of ongoing Agency efforts to encourage the submission of supplemental applications for new uses for approved drug and biological products. The guidance also is consistent with section 403 of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act), which specifies that the FDA will continue its efforts to encourage sponsors to submit supplemental applications for new uses for their products. This guidance for industry discusses the quality and quantity of data that may be adequate to add a new use to the prescribing information for a product used in the treatment of cancer. It also describes specific steps FDA is taking to foster the updating of labeling for products used in cancer treatment.


Submit Comments

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:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.