Conflicting signals on US accelerated approvals

被引:3
|
作者
Fox, JL
机构
关键词
D O I
10.1038/nbt0905-1027
中图分类号
Q81 [生物工程学(生物技术)]; Q93 [微生物学];
学科分类号
071005 ; 0836 ; 090102 ; 100705 ;
摘要
The results of a phase 3 clinical study on the lung cancer drug Iressa (gefitinib) have revealed that the drug did not produce a significant survival advantage over placebo. Since then some FDA critics contend that the accelerated review process should be slowed, whereas others fear that heightened anxieties about safety could undermine a program that provides therapeutics more quickly to needy patients.
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页码:1027 / 1028
页数:2
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