美国FDA 指导原则 用于传输个案安全报告的E2BM数据元素 英文原版.pdf

Guidance for Industry E2BM Data Elements for Transmission Of Individual Case Safety Reports U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) April 2002 ICH Revision 1 Guidance for Industry E2BM Data Elements for Transmission Of Individual Case Safety Reports Additional copies are available from: Office of Drug Information (HFD-240) Center for Drug Evaluation and Research (CDER), 5600 Fishers Lane, Rockville, MD 20857 (Tel) 301-827-4573 /cder/guidance/index.htm or Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER) 1401 Rockville Pike, Rockville, MD 20852-1448, /cber/guidelines.htm; (Fax) 888-CBERFAX or 301-827-3844 (Voice Information) 800-835-4709 or 301-827-1800 U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) April 2002 ICH Revision 1