FDA Applications for Premarket Review of New Tobacco Products Draft Guidance for Industry
标准简介
Applications for Premarket Review of New Tobacco Products Draft Guidance for Industry[附网盘链接]由FDA于不久之前发布，适用于US。标准截图
![Applications for Premarket Review of New Tobacco Products Draft Guidance for Industry[附网盘链接]](/img/20210914103556blf57.jpg)
标准文档说明
标准文档类型为Applications for Premarket Review of New Tobacco Products Draft Guidance for Industry[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
Contains Nonbinding Recommendations Draft — Not for Implementation 1 Guidance for Industry Applications for Premarket Review of New Tobacco Products
This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. I. Introduction This draft guidance is intended to assist persons submitting applications for new tobacco products under section 910 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act; 21 U.S.C. 301 et seq.), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Public Law 111-31). This draft guidance explains, among other things: • Who may submit a new tobacco product application under section 910 of the FD&C Act (21 U.S.C. 387j); • When to submit a new tobacco product application; • How to submit a new tobacco product application; • What information the FD&C Act requires you to submit in a new tobacco product application; and • What information FDA recommends you submit in a new tobacco product application. FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required. 1 This guidance was prepared by the Office of Science and Office of Regulations in the Center for Tobacco Products at FDA.
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