Challenges in Implementing Revocation of Oncology Drugs Under Conditional Early Approval in Japan: Regulatory Insights From Comparisons With FDA/EMA
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Expedited pathways in the United States (U.S.), European Union (EU), and Japan (JP) enable earlier access to innovative therapies for rare and serious diseases. In 2025, Japan explicitly introduced revocation provisions to its Conditional Early Approval (CEA).... ...
