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。
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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