美国FDA 指导原则 提供电子格式的法规提交-标签内容 英文原版.pdfVIP

Guidance for Industry Providing Regulatory Submissions in Electronic Format — Content of Labeling 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 2005 Electronic Submissions Guidance for Industry Providing Regulatory Submissions in Electronic Format — Content of Labeling Additional copies are available from: Office of Training and Communications Division of Drug Information, HFD-240 Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 (Tel) 301-827-4573 /cder/guidance/index.htm or Office of Communication, Training and Ma nufacturers Assistance, HFM-40 Center for Biologics Evaluation and Research Food and Drug Administration 1401 Rockville Pike, Rockville, MD 20852-1448 /cber/guidelines.htm Phone: the Voice Information System at 800 -835-4709 or 301-827-1800 U.S. Department of Health and Human Services Food and Drug Administration