美国FDA 指导原则 向食品添加剂安全办公室提供电子或纸质格式法规提交的行业指南 英文原版.pdfVIP

Contains Nonbinding Recommendations Draft-Not for Implementation Guidance for Industry Providing Regulatory Submissions in Electronic or Paper Format to the Office of Food Additive Safety Draft Guidance You may submit written comments regarding this guidance at any time. Submit written comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the title of the guidance document. Additional copies are available from: Office of Food Additive Safety (HFS-200) Center for Food Safety and Applied Nutrition Food and Drug Administration 5001 Campus Drive College Park, MD 20740 (Tel) 301-436-1200 /FoodGuidances U.S. Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition March 2010 Contains Nonbinding Recommendations Draft-Not for Implementation Table of Contents I. Introduction II. Elements Common to All Regulatory Submissions A. General B. Forms C. Amendments, Updates, and Supplements D. Table of Contents E. Information that is Exempt from Disclosure under the Freedom of Information Act (FOIA) F. Cover Letter G. References III. General Considerations about Regulatory Submissions in Electronic Format A. General Information B. Tra