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Moderna accuses FDA of shifting standard as agency refuses flu shot review
莫德纳指控FDA在拒绝审查其流感疫苗时“改变标准”

The FDA said it won’t review Moderna’s flu vaccine application, a surprise decision that the company is describing as a shifting of the standards for its pivotal trial well after it thought it had reached an agreement.
美国食品药品监督管理局(FDA)表示不会审评莫德纳流感疫苗的申报。此举出人意料,莫德纳称监管方在其认为已达成一致后,仍在关键性试验上改变了评估标准。

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The FDA said it won’t review Moderna’s flu vaccine application, a surprise decision that the company is describing as a shifting of the standards for its pivotal trial well after it thought it had reached an agreement.

美国FDA表示将不予审查莫德纳的流感疫苗申请。该公司称,这一出人意料的决定相当于在其认为已达成一致很久之后,又改变了针对其关键性试验的评审标准。

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