FDA Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics
标准简介
Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics[附网盘链接]是Food And Drug Administration于不久之前发布的FDA标准，适用于United States。标准截图
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标准文档说明
标准文档类型为Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
Clinical Trial Endpoints for the Approval of
Non-Small Cell Lung Cancer Drugs and Biologics
1
Guidance for Industry This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not create any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page. I. INTRODUCTION The purpose of this guidance is to provide recommendations to applicants on endpoints for non-
small 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), 2
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 3 Drugs and Biologics. This guidance addresses the FDA’s current thinking regarding efficacy endpoints in trials to evaluate drugs to treat lung cancer and takes into account discussions held at a public workshop (April 15, 2003) and at a meeting of the FDA’s Oncologic Drugs Advisory Committee (ODAC) 4
(December 16, 2003). This guidance does not address efficacy endpoints for drugs intended to prevent or decrease the incidence of lung cancer. 1
This guidance has been prepared by the Division of Oncology Products 2 in the Center for Drug Evaluation and Research (CDER) in cooperation with the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration. 2
For the purposes of this guidance, all references to drugs include both human drugs and therapeutic biological products unless otherwise specified. 3 We update guidances periodically. To make sure you have the most recent version of a guidance, check the FDA Drugs guidance Web page at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. 4
Transcripts are available at http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm117709.htm#lung and http://www.fda.gov/ohrms/dockets/ac/03/transcripts/4009T1.pdf. 1
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