Accelerated Approval Is Not Conditional Approval Insights From International Expedited Approval Programs

Mehta, GU; de Claro, RA; Pazdur, R

Mehta, GU (通讯作者),US FDA, Ctr Drug Evaluat & Res, 10903 New Hampshire Ave,Bldg 22, Silver Spring, MD 20993 USA.

JAMA ONCOLOGY, 2022; 8 (3): 335

Abstract

This Viewpoint compares the US Food and Drug Administration's accelerated approval pathway for drugs and biologics with similar programs developed by ......

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