FDA Early Clinical Trials With Live Biotherapeutic Products Chemistry, Manufacturing, and Control Information
标准简介
Early Clinical Trials With Live Biotherapeutic Products Chemistry, Manufacturing, and Control Information[附网盘链接]是Food&Drug Administration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Early Clinical Trials With Live Biotherapeutic Products Chemistry, Manufacturing, and Control Information[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
Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information Guidance for Industry This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish 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 A. Purpose and Scope We, FDA (or Agency), are providing you, Investigational New Drug Application (IND) sponsors, with recommendations regarding IND submissions for early clinical trials with live biotherapeutic products (LBPs) in the United States (U.S.), including LBPs lawfully marketed as foods (such as conventional foods and dietary supplements) in the U.S. and proposed for clinical uses regulated under section 351 of the Public Health Service (PHS) 1
Act (42 U.S.C. 262). This guidance focuses on the chemistry, manufacturing, and control (CMC) information that you should submit in an IND for an LBP. This guidance is applicable to all INDs of LBPs, whether clinical trials are conducted commercially, in an academic setting, or 2
otherwise under Title 21 of the Code of Federal Regulations Part 312 (21 CFR Part 312). 1
The term “live biotherapeutic product” is defined in the “definitions” section (section I.B.) of this document. 2
This guidance is not intended to address when an IND is required prior to conducting clinical trials. For further discussion of that subject see “Guidance for Clinical Investigators, Sponsors, and IRBs: Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can Be Conducted Without an IND” dated September 2013, available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM229175.pdf. A stay is in effect for parts of this guidance document. See “Investigational New Drug Applications – Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug; Guidance for Clinical Investigators, Sponsors, and IRBs; Partial Stay and Republication of Guidance” (80 FR 66907, October 30, 2015).
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