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