FDA Changes to an Approved Application Biological Products Human Blood and Blood Components Intended for Transfusion or for Further Manufacture Final Guidance
标准简介
Changes to an Approved Application Biological Products Human Blood and Blood Components Intended for Transfusion or for Further Manufacture Final Guidance[附网盘链接]由Food&Drug Administration于之前发布，适用于US。标准截图
![Changes to an Approved Application Biological Products Human Blood and Blood Components Intended for Transfusion or for Further Manufacture Final Guidance[附网盘链接]](/img/202109141036071pftb.jpg)
标准文档说明
标准文档类型为Changes to an Approved Application Biological Products Human Blood and Blood Components Intended for Transfusion or for Further Manufacture Final Guidance[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture Guidance for Industry This guidance represents the Food and Drug Administration’s (FDA’s or Agency’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. I. INTRODUCTION We, FDA, are providing you, manufacturers of licensed Whole Blood and blood components intended for transfusion or for further manufacture, including Source Plasma, with recommendations intended to assist you in determining which reporting mechanism is appropriate for submission of changes to an approved Biologics License Application (BLA) in accordance with the requirements under Title 21 of the Code of Federal Regulations (CFR) 601.12 (21 CFR 601.12), including recommendations in connection with the applicability and content of comparability protocols under 21 CFR 601.12(e) and labeling changes under 21 CFR 601.12(f). This guidance finalizes the draft guidance of the same title dated June 2013 (78 FR 32668, May 31, 2013) and supersedes the guidance entitled, “Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture” dated July 2001 (66 FR 41247, August 7, 2001) (Ref. 1). FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA’s guidances means that something is suggested or recommended, but not required.
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