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Adverse Event Reporting System : ウィキペディア英語版 | Adverse Event Reporting System The Adverse Event Reporting System (AERS) is a computerized information database designed to support the U.S. Food and Drug Administration's (FDA) post-marketing safety surveillance program for all approved drug and therapeutic biologic products. The FDA uses AERS to monitor for new adverse events and medication errors that might occur with these marketed products. ==Background== Reporting of adverse events from the point of care is voluntary in the United States. FDA receives some adverse event and medication error reports directly from health care professionals (such as physicians, pharmacists, nurses and others) and consumers (such as patients, family members, lawyers and others). Healthcare professionals and consumers may also report these events to the products’ manufacturers. If a manufacturer receives an adverse event report, it is required to send the report to FDA as specified by regulations. The MedWatch site provides information about mandatory reporting.
抄文引用元・出典: フリー百科事典『 ウィキペディア(Wikipedia)』 ■ウィキペディアで「Adverse Event Reporting System」の詳細全文を読む
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