The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
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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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