Ball R, Robb M, Anderson S A, Dal Pan G
Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
Clin Pharmacol Ther. 2016 Mar;99(3):265-8. doi: 10.1002/cpt.320. Epub 2016 Jan 12.
In May 2008, the Department of Health and Human Services announced the launch of the Sentinel Initiative by the US Food and Drug Administration (FDA) to create the Sentinel System, a national electronic system for medical product safety surveillance. This system complements existing FDA surveillance capabilities that track adverse events reported after the use of FDA regulated products by allowing the FDA to proactively assess the safety of these products.
2008年5月，美国卫生与公众服务部宣布美国食品药品监督管理局（FDA）启动哨兵计划，以创建哨兵系统，这是一个用于医疗产品安全监测的全国性电子系统。该系统通过使FDA能够主动评估这些产品的安全性，对FDA现有的监测能力起到补充作用，FDA现有的监测能力用于追踪使用FDA监管产品后报告的不良事件。
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