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GUIDANCE DOCUMENT

Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics April 2015

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2011-D-0432
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center 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.

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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:

Dockets Management
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.

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