The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
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JaDHA Creates Hypothetical Case Collection to Push Two-Stage Approval of SaMD
The Japan Digital Health Alliance (JaDHA) has drawn up a collection of hypothetical cases of therapeutic software as a medical device (SaMD) in a bid to add impetus to the development of these products envisioning the two-step approval pathway. JaDHA…
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