美国FDA 指导原则 来源动物产品关于人类使用异种移植产品的临床前和临床问题工业指南 英文原版.pdf

Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans ______________________________________________________________________________ Guidance for Industry Additional copies of this guidance are available from the Office of Communication, Outreach and Development (OCOD), 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002, or by calling 1-800-835-4709 or 240-402-8010, or email ocod@, or from the Internet at /BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guida nces/default.htm. For questions on the content of this guidance, contact OCOD at the phone numbers or email address listed above. U.S. Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research April 2003 Updated December 2016 Contains Nonbinding Recommendations Table of Contents I. INTRODUCTION 1 II. BACKGROUND 2 III. DEFINITIONS AND ABBREVIATIONS 3 IV. REGULATORY RESPONSIBILITY 7 V. SOURCE ANIMAL CHARACTERIZATION 7 A. General Considerations 7 B. Animal Welfare Concerns 8 C. Animal Origin 9 D. Animal Health and Husbandry 11 E. Harvest of Nonhuman Live Cells, Tissues, or Organs for Use in Producing Xenotransplantation Products 17 F. Source Animal History for Xenogeneic Cell Lines 20 G. Disposal of Animals and Use of Byproducts 21 VI.