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美国食品和药品管理局(FDA)颁布的加框警语,常称为“黑框”警语,用做标记有严重副作用的药物。通过负性事件报告系统和监督及流行病学办公室对这些安全性进行识
The boxed warning issued by the U.S. Food and Drug Administration (FDA), often called the “black box”, is used as a drug labeled with serious side effects. Knowledge of these safety through the Negative Incident Reporting System and the Office of Oversight and Epidemiology