美国FDA 指导原则 为工业和食品药品监督管理局工作人员提供的生产现场变更补充内容和提交指南 英文原版.pdfVIP

Contains Nonbinding Recommendations Manufacturing Site Change Supplements: Content and Submission Guidance for Industry and Food and Drug Administration Staff Document issued on December 17, 2018. The draft of this document was issued on October 21, 2015. For questions about this document regarding CDRH-regulated devices, contact the Premarket Approval Staff at 301-796-5640. For questions about this document regarding CBER-regulated devices, contact the Office of Communication, Outreach and Development (OCOD) by calling 1-800-835-4709 or 240-402- 8010. U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Center for Biologics Evaluation and Research Contains Nonbinding Recommendations Preface Public Comment You may submit electronic comments and suggestions at any time for Agency consideration to . Submit written comments to the Dockets Management Staff, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852. Identify all comments with the docket number FDA-2015-N-3454. Comments may not be acted upon by the Agency until the document is next revised or updated. Additional Copies CDRH Additional copies are available from the Internet. You may also send an e-mail request to CDRH-Guidance@ to receive an electronic copy of the guidance. Please use the document number 1269 to identify the guidance you are requesting. CBER Additional copies are available from the Center for Biologics Evaluation and Research (CBER) by wri