FDA Demonstrating the Substantial Equivalence of a New Tobacco Product Responses to Frequently Asked Questions
标准简介
Demonstrating the Substantial Equivalence of a New Tobacco Product Responses to Frequently Asked Questions[附网盘链接]是Food And Drug Administration发布的FDA标准，适用于US。标准截图
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标准文档说明
标准文档类型为Demonstrating the Substantial Equivalence of a New Tobacco Product Responses to Frequently Asked Questions[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
1 Guidance for Industry Demonstrating the Substantial
Equivalence of a New Tobacco Product:
Responses to Frequently Asked Questions
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 This guidance provides information in response to frequently asked questions (FAQs) that the Center for Tobacco Products (CTP) has received from manufacturers and other interested stakeholders (you) on demonstrating the substantial equivalence (SE) of a new 2
tobacco product. Among ot her things, this guidance includes information on FDA’s current thinking on whether a change to the product quantity in the package renders a product “new” and thus subject to premarket review. FDA is issuing this revised final guidance following a decision by the United States 3
District Court for the District of Columbia. The court found that “a modification to an 4
existing product’s label does not result in a ‘new tobacco product.’” Accordingly, manufacturers need not receive premarket authorization for existing products that are the 1 This guidance was prepared by the Office of Science and Office of Regulations in the Center for Tobacco Products at FDA. 2 FDA first issued guidance regarding SE applications in a guidance entitled, “Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco P roducts” (Demonstrating SE Guidance), which is available on the Internet at http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM23902 1.pdf The notice of availability for this guidance published on January 6, 2011 (76 Federal Register 789). 3 The previous version of this guidance published September 8, 2015 (80 Federal Register 53810). Please note that in this current version of the guidance, FDA refers to “SE Reports” as “SE applications,” but the terms both refer to a premarket submission under section 905(j)(1)(A) of the FD&C Act. 4 Philip Morris USA Inc. v. United States Food and Drug Administration, ___ F. Supp. 3d ___, No. 15
cv1590 (APM), 2016 WL 4378970 (D.D.C. Aug. 16, 2016). 1
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