美国FDA 指导原则 如何撰写指定申请(RFD) 英文原版.pdfVIP

Guidance for Industry How to Write a Request for Designation (RFD) U.S. Department of Health and Human Services Food and Drug Administration Office of the Commissioner Office of Combination Products April 2011 Guidance for Industry How to Write a Request for Designation (RFD) For questions regarding this document, contact: Office of Combination Products (OCP) at 301-796-8930 or combination@ Public Comment Written comments and suggestions may be submitted at any time for Agency consideration to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. When submitting comments, please refer to the exact title of this guidance document. Comments may not be acted upon by the Agency until the document is next revised or updated. Additional copies are available from: Office of Combination Products Office of the Commissioner Food and Drug Administration WO32 Hub/Mail Room #5129 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 (Tel) 301-796-8930, (Fax) 301-847-8619 combination@ /combinationproducts/ ii TABLE OF CONTENTS I. PURPOSE 1 II. GENERAL INFORMATION REGARDING THE REQUEST FOR DESIGNATION PROCESS FOR NON-COMBINATION AND COMBINATION PRODUCTS2 A. What is a non-combination product? 2 B. What is a combination product? 3 C. What is a Request for Designation?3 D. When