FDA会因为不能检查而延长批准期限吗?恢复检查后的期限是什么?
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2022-05-19 20:23 匿名     
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FDA针对新冠疫情期间的相关检查,专门发布了《Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers》(COVID-19公共卫生紧急事件期间生产、供应链、药品和生物制品检查问答)文件,针对疫情下实施检查的具体操作有相关说明,其中第6个问题就提到了: If my application includes sites that cannot be inspected because of travel restrictions resulting from the public health emergency will my application automatically receive a complete response letter? 如果我的申请包含因突发公共卫生事件导致的旅行限制而无法检查的地点,我的申请是否会自动收到完整的回复信?


该系列问答来自【视频】如果FDA恢复境外检查会发生什么

2022-05-19 20:24 tooth