FDA行业指南-电子注册及药品备案的呈交(原文).pdf

Guidance for Industry Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing U.S. Department of Health and Human Services Food and Drug Administration Office of the Commissioner May 2009 Electronic Submission OMB Control No. 0910-0045 Expiration Date: 3/31/2012 See additional PRA statement in Section VII of this guidance Contains Nonbinding Recommendations Guidance for Industry Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing Additional copies are available from: Office of Training and Communication 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 and/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 /cber/guidelines.htm (Tel) 800-835-4709 or 301-8