- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter for Biologics Evaluation and Research
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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2011-D-0432.