2021年8月10日,FDA对福建漳州BBC Group Limited就数据完整性、交叉污染和缺乏文件问题出具警告信。详细情况如下: The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, BBC Group Limited, FEI 3010165327, at Yangxia Dev...
effectiveness, and quality of the drugs you analyze for your customers. See FDA’s guidance documentData Integrity and Compliance With Drug CGMPfor guidance on establishing and following CGMP compliant data integrity practices at https://www.fda.gov/regu...
此外,如果登记数据由第三方拥有和控制 , 申办人应达成协议以确保所有相关的患者级别数据都可以提供给 FDA,并且源记录可供检查。 原文链接:https://www.fda.gov/regulatory-information/search-fda-guidance-documents/real-world-data-assessing-registries-support-regulatory-decision-making-drug-and-biological-products...
FDA’sguidance documents should be viewed only as recommendations, unless specificregulatory or statutory requirements are cited. The use of the word should in Agency guidances means thatsomething is suggested or recommended, but not required. FDA的指南文件应仅看作是建议,其中引用的具体法律法规要求除外。
在2021年1月份,FDA继续秉持公开透明的工作原则,发布了2021年度CDER的指南修订和制订工作计划《CDER Guidance Agenda-New & Revised Draft Guidance Documents Planned for Publication in Calendar Year 2021》。从这份年度工作计划中,可以看出FDA将在多个监管领域启动指南文件的修订和制订工作,并进一步影响国际制药行业。笔...
1. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/real-world-data-assessing-electronic-health-records-and-medical-claims-data-support-regulatory 2. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-standards-drug-and-biological-product-submissions-con...
FDA guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirement s are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required. 本文件的内容不具有法律效力,...
FDA’s guidance document Data Integrity and Compliance With Drug CGMP for guidance on establishing and following CGMP compliant data integrity practices at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-integrity-and-compliance-drug-cgmp-questions-and-answers-guidance-...
Transporter-Mediated Drug Interactions (2020, FDA) https://www.fda.gov/regulatory-information/search-fda-guidance-documents/vitro-drug-interaction-studies-cytochrome-p450-enzyme-and-transporter-mediated-drug-interactions [2] 药物相互作用研究技术指导原则(试行)(NMPA 2021年1月) http://www.cde.org.cn/...
为了指导检查员开展药品生产设施的PAI,美国FDA制定了PAI合规项目手册(Compliance Program Guidance Manual 7346.832 Preapproval Inspections, CPGM7346.832)[1]。自首次发布以来,随着行业整体水平的不断提升和科学认知的持续深入,美国FDA正不断优化内部机构,引入先进理念,并基于风险对CPGM 7346.832进行了多次重大修订,如...