美国FDA 指导原则 以电子格式提交意见书-售后非加急ICSR技术问题和解答 英文原版.pdfVIP

Guidance for Industry Providing Submissions in Electronic Format – Postmarket Non-Expedited ICSRs Technical Questions and Answers 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) July 2013 Electronic Submissions Guidance for Industry Providing Submissions in Electronic Format – Postmarket Non-Expedited ICSRs Technical Questions and Answers Additional copies are available from: Office of Communications Division of Drug Information, WO51, Room 2201 10903 New Hampshire Ave. Silver Spring, MD 20993 Phone: 301- 796-3400; Fax: 301-847-8714 druginfo@ /Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm (Tel) 240-276-9300 or Office of Communication, Outreach and Development, HFM-40 Center for Biologics Evaluation and Research Food and Drug Administration 1401 Rockville Pike, Rockville, MD 20852-1448 ocod@ /BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm Phone: 800-835-4709 or 301-827-1800 U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Eval