...rough Therapy）：用于重症治疗的药物，且早期临床数据表明，临床疗效可能明显优于现有疗法。 加速批准（Accelerated Approval）：用于重症治疗的药物，且在某些方面优于现有疗法，并有一个替代性的临床指标，据此能够比较合理地预测出药物的临床有效性，或有...
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...加速审批；优先审评 [gap=1819]edite development program; serious conditions; fast tract; breakthrough therapy; accelerated approval; priority review ...
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3)加快审批(Accelerated Approval)：加快审批允许在确切的治疗效益证据未全部收集到之前批准新药上市，即在临床结果还未能充分证明其安全有效之前就能批准上市。
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The drug was approved under the FDA's accelerated approval program.
该药是通过FDA的加快审批程序而获批的。
Under accelerated approval, the company is required to conduct additional clinical trials after approval to confirm the drug's benefit.
在加速认证的情况下，公司被要求进行附加的临床试验以确认该药物的益处。
Since 1992, the FDA has granted accelerated approval to drugs based on so-called surrogate endpoints, or initial measures that suggest the drug will make real improvements in patient health.
自从1992年起，FDA认为对那些基于所谓替代终点、或是被认为药物将使病人健康得到改善的药品实行加快审批是理所应当的。
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