美国FDA 指导原则 除血液和血液成分外的持牌生物制品制造商的生物制品偏差报告 英文原版.pdfVIP

Guidance for Industry Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other than Blood and Blood Components Additional copies of this guidance document are available from the Office of Communication, Training and Manufacturers Assistance, (HFM-40), 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448, or by calling 1-800-835-4709 or 301-827-1800, or from the Internet at /cber/guidelines.htm. or Office of Training and Communication, Division of Drug Information, HFD-240, Center for Drug Evaluation and Resear