FDA 3674 - Certifications To Accompany Drug, Biological Product, and Device ApplicationsSubmissions
标准简介
3674 - Certifications To Accompany Drug, Biological Product, and Device ApplicationsSubmissions[附网盘链接]是于当前发布的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3674 - Certifications To Accompany Drug, Biological Product, and Device ApplicationsSubmissions[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
Form FDA 3674 - Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff 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 office responsible for this guidance as listed on the title page. I. Introduction This guidance describes the Food and Drug Administration’s (FDA, we, or Agency) current thinking regarding the types of applications and submissions that sponsors, industry, researchers, and investigators submit to FDA with accompanying certifications (Form FDA 3674) under section 402(j)(5)(B) of the Public Health Service Act (PHS Act), 42 U.S.C. § 282(j)(5)(B). Section 402(j) of the PHS Act was added by Title VIII, Food and Drug Administration Amendments Act of 2007 (FDAAA) (Public Law 110-85). FDA’s guidance documents, including this guidance, do not establish legally enforceable rights or responsibilities. Instead, guidances describe FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.
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