美国FDA 指导原则 申请烟草新产品上市前审查行业指导意见草案 英文原版.pdfVIP

Guidance for Industry Applications for Premarket Review of New Tobacco Products DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. Alternatively, electronic comments may be submitted to . 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 For questions regarding this draft guidance, contact the Center for Tobacco Products at (Tel) 1-877- 287-1373 or refer to: /TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm. U.S. Department of Health and Human Services Food and Drug Administration Center for Tobacco Products September 2011 Contains Nonbinding Recommendations Draft — Not for Impl ementation Guidance for Industry Applications for Premarket Review of New Tobacco Products DRAFT GUIDANCE Additional copies are available online at: /TobaccoProducts You may also send an e-mail request to AskCTP@ to receive an electronic copy of the guidance. U.S. Department of Health and Human Services Food and Drug Administration Center for Tobacco Products September