accelerated approval program
accelerated approval program
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加速审批计划
DOI：
10.1007/978-3-211-89836-9_7
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发表时间：
2009
期刊：
影响因子：
--
通讯作者：
G. Nahler
中科院分区：
文献类型：
--
作者：
G. Nahler
syn. fast track procedure; approval of therapies “that provide a meaningful therapeutic benefit for patients with serious illness” (FDA) will be accelerated; a similar procedure exist in the EC; in this case, approval relies solely or in part on surrogate endpoints for evidence of effectiveness; the average duration for marketing authorisation in the US takes more than 20 months; in an accelerated approval program substances are classified according to their therapeutic potential in P (priority) and S (standard) substances; → seeapproval, new drug application, surrogate endpoint.
