Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
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PMDA to Adopt General-Purpose AI in FY2025, Eyes Specialized Tools for Reviews and Safety Work
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) plans to introduce general-purpose AI during FY2025 to streamline administrative tasks such as drafting meeting minutes, while also exploring the longer-term use of more specialized AI for regulatory work. PMDA Senior Executive Director…
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