向FDA提交不良事件和用药错误报告链接:https://www.fda.gov/Safety/MedWatch/HowToReport/default.htm FDA企业强制报告电子递交网站:https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm115894.htm FAERS Statistics链接:https://www.fda.gov/Drugs/GuidanceComplianceRegu...
If a potential safety concern is discovered in FDA Adverse Event Reporting System (FAERS), further evaluation is performed. Based on the evaluation, FDA may take regulatory action(s) to improve product safety and protect public health, such as: Restricting the use of the drug Updating a pro...
The FDA drug safety surveillance program: adverse event reporting trends. Arch Intern Med. 2011;171(6):591–3.Weiss-Smith S, Deshpande G, Chung S, Gogolak V. The FDA drug safety surveillance program: adverse event reporting trends. Arch Intern Med. 2011; 171 (6):591–593. doi: 10.1001...
FDA Adverse Event Reporting System (FAERS) Quarterly Data Files FDA不良事件报告系统(FAERS)季度数据文件Downloadable data files. 可下载的数据文件 FDA Adverse Event Reporting System (FAERS) Public Dashboard FDA不良事件报告系统(FAERS)公告板 Inactive Ingredient Search for Approved Drug Products Search获批药...
Maintained by the United StatesFood and Drug Administration (FDA). Two Methodology Documents: ASC_NTS.DOCincluded in eachquarterly zipped file, especially the Entity Relationship Diagram Questions and Answers on FDA’s Adverse Event Reporting System (FAERS) ...
FDA有几乎近35年的时间在收集不良反应事件的纸质报告,自2001年起许多制药企业自愿向审查机构提交药品和非疫苗生物制品的电子版报告,所收集的纸质报告和电子版报告均纳入FDA不良反应事件报告系统(the FDA Adverse Event Reporting System,FAERS)。FDA于2009年8月21日,FDA在《联邦公报》发布《人用药品和生物制品上市后安...
与旧版本不同的是,新版本对OTC药品进行收录。 2、药品上市后监测 2.1 、FDA Adverse Event Reporting System (FAERS)(formerly AERS) 不良反应报告系统。 2.2、Postmarket Requirements and Commitments 上市后要求和承诺。
该文件描述了向 FDA 递交 ICSR、纳入其区域控制术语以及添加 FDA 不良事件报告系统 (FDA Adverse Event Reporting System ，FAERS) 区域数据元素的技术方法，这些数据元素在ICH的 E2B (R3) 实施指南 (IG) 中未涉及，适用于以下 FDA 监管产品：• 已获新药申请（NDA）和简略新药申请（ANDA）批准的人用药物...
·Form FDA 3500A (PDF - 903KB): Medwatch: The FDA Safety Information and Adverse Event Reporting Program - Mandatory,"MedWatch安全信息和不良反应报告计划-强制报告"。该表格用于强制性地报告医疗产品相关的不良事件、产品问题和质量问题。要求特定的报告人,如医疗机构和制造商,根据法律或监管要求向FDA提供报...
在本次讲座中,孙教授首先从药物警戒学出发,介绍了FDA不良事件报告系统 (FDA Adverse Event Reporting System, FAERS),然后重点以“基于真实世界数据的达托霉素药物不良反应信号数据挖掘:FAERS不成比例性分析”这篇文章 [Chen, JJ., Huo, XC., Wang, SX. et al. Data mining for adverse drug reaction signals ...