Guidance for Industry. FDA Approval of New Cancer Treatment Uses for Marketed211 Drug and Biological Products

摘要

This document provides guidance to sponsors planning to file applications for new211u001euses of marketed drug and biological products for the treatment of cancer. This 211u001eguidance for industry is part of ongoing Agency efforts to encourage the 211u001esubmission of supplemental applications for new uses for approved drug and 211u001ebiological products. The guidance also is consistent with section 403 of the Food 211u001eand Drug Administration Modernization Act of 1997 (the Modernization Act), which 211u001especifies that the FDA will continue its efforts to encourage sponsors to submit 211u001esupplemental applications for new uses for their products. This guidance for 211u001eindustry discusses the quality and quantity of data that may be adequate to add a 211u001enew use to the prescribing information for a product used in the treatment of 211u001ecancer. It also describes specific steps FDA is taking to foster the updating of 211u001elabeling for products used in cancer treatment.