更新一下后续,审核时间可以详见指南 FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals - Guidance for Industry and Food and Drug Administration Staff, Section D. MDUFA V Goal, Table 1: MDUFA V Decision Goals.
但又有新的疑问:不同的递交类型有什么区别?什么情况下需要选择不同的递交类型?