The purpose of this guidance is to provide recommendations to applicants on endpoints for nonsmall cell lung cancer (NSCLC) clinical trials of drugs that are submitted to the Food and Drug Administration (FDA) to support effectiveness claims in new drug applications (NDAs), biologics license applications (BLAs), or supplemental applications. This guidance is a companion to the guidance for industry Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics.
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.