By referring to the laws and regulations of the United States, FDA guidance documents and implementation guidelines, related news, domestic and foreign literature, we analyzed more deeply the background, content system, social disputes caused by the Right to Try Act and its important breakthroughs of the existing expanded access in this paper, so as to provide reference for the system innovation in China. Although the Right to Try Act emphasizes deregulation, simplification of procedures and relative risk control, it also emphasizes the widening of critically ill patients' right of free choice. Therefore, it is required that the introduction and construction of relevant system norms be comprehensively measured and prudently promoted in Chinese context.

Right to Try Act  /  clinical trial  /  expanded access  /  option