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Reversal on Moderna's flu application follows atypical path through FDA
摩德纳流感疫苗申请遭逆转,走了一条非典型的FDA审评路径

The decision by the FDA on Wednesday to reverse course and review Moderna’s flu vaccine application was the result of a meeting Tuesday between an unusual group of senior FDA leaders and Moderna, with the FDA leaders walking back their boss’ overruling, according to two sources familiar with the meeting.
两名知情人士透露,FDA周三决定改弦易辙、重新审查Moderna的流感疫苗申请,此前一天,FDA的一组不同寻常的高级领导与Moderna举行了会面,这些FDA高层在会上推翻了其上司的否决。

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The decision by the FDA on Wednesday to reverse course and review Moderna’s flu vaccine application was the result of a meeting Tuesday between an unusual group of senior FDA leaders and Moderna, with the FDA leaders walking back their boss’ overruling, according to two sources familiar with the meeting.

两位知情人士称,美国食品药品监督管理局(FDA)周三决定掉头重新审查摩德纳的流感疫苗申请,此举源于该机构一群不同寻常的高级领导人与摩德纳在周二举行的一次会议。在会上,这些FDA高级负责人对其上司作出的推翻决定又收回成命。

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