Japan's Conditional/Time‐Limited Early Approval System in Regenerative Medicine: A Case Study of Rise and Falls of Autologous Skeletal Myoblast Sheets
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DOI: 10.1002/cpt.3562
Abstract: Japan's conditional/time‐limited early approval program, initiated in 2014, aimed to advance regenerative medicine by expediting market access. However, the withdrawal of autologous skeletal myoblast sheets (Heartsheet) due to ineffectiveness raises concerns about the balance between… read more here.
Keywords: conditional time; japan conditional; approval; medicine ... See more keywords