Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
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PMDA Sets Target Duration of SaMD Priority Reviews to 6 Months in FY2024 Plan
The Pharmaceuticals and Medical Devices Agency (PMDA) has set a target of six months for the total review period of products filed under the software as a medical device (SaMD) priority review system. This plan was presented at a steering…
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