美国FDA 指导原则 使用调查性烟草产品行业和调查人员指南草案 英文原版.pdfVIP

Use of Investigational Tobacco Products Guidance for Industry and Investigators DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments regarding this draft guidance may be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Electronic comments may be submitted to . Alternatively, submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD, 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register . For questions regarding this draft guidance, contact the Center for Tobacco Products at (Tel) 1- 877-CTP-1373 (1-877-287-1373), Monday-Friday, 9 a.m. – 4 p.m. EDT. Additional copies are available online at /TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm . You may send an email request to SmallBiz.Tobacco@ to receive an electronic copy of this guidance. You may send a request for hard copies to U.S. Food and Drug Administration, Center for Tobacco Products, Attn: Office of Small Business Assistance, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-2000. U.S. Department of Health and Human Services Food and Drug Administration Center for Tobacco Products February 2019 Table of Contents Guidance for Industry and Investigators 1 I. INTRODUCTION 1 II. BACKGROUND 2 III. PURPOSE 5 IV. FDA’S ENFORCEMENT POLICY FOR INVESTIGATIONAL TOBACCO PRODUCTS 6 V. INFORMATION REGARDING PROPOSED USE OF AN INVESTIGAT