PDF(813 KB)
美国FDA药品审评决策反馈机制中完整回复函制度对我国药品监管的启示
陆建, 沙明泉, 董美意, 白玉
PDF(813 KB)
PDF(813 KB)
美国FDA药品审评决策反馈机制中完整回复函制度对我国药品监管的启示
The complete response letter in FDA's review decision feedback mechanism and its implications for China
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