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FDA,“余震”不断
而继续沿着事实逻辑看,就会发现,在FDA资深人士大批离开后,新药评审所需的专业能力是减弱而非得到加强。因此,行业的观察是,FDA对新的IND、BLA以及NDA的审批速度将大大减慢,许多产品和公司可能要“面临漫长而昂贵的停滞期,迟迟得不到任何进展”。
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