The drug was approved under the FDA's acceleratedapproval program.
该药是通过FDA的加快审批程序而获批的。
2
Under acceleratedapproval, 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。
3
Since 1992, the FDA has granted acceleratedapproval to drugs based on so-called surrogate endpoints, or initial measures that suggest the drug will make real improvements in patient health.