摘要:本文主要汇总公众和企业向FDA提交不良事件报告的途径、形式和报告中包含的基本信息,简要介绍食品安全与应用营养中心不良事件报告系统(CAERS),汇总并分析近年CAERS数据库中收录的不良事件和投诉的数据信息,重点介绍FDA食品安全与应用营养中心关于膳食补充剂、婴儿配方乳粉和医用食品这三类产品不良事件报告监管情况,为我国相关产品监管提供一定的参考。
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