JAPAN | PMDA Proposes Review Points for Generative-AI Medical Devices — Real-World Performance and Lifecycle Monitoring Move Into Focus
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JAPAN | Post-Marketing Evidence Supports Paediatric Melatonin Label Revision — Trial Evidence Gap Remains Explicit
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JAPAN | PMDA Perspective on RWD and RWE USE for Regulatory Purposes
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JAPAN | Updated PMDA RMP Guidance
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