The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
REGULATORY
MHLW Revises Safety Guidance on FIH Studies Following Death of Subject
The Pharmaceutical Evaluation Division of the Ministry of Health, Labor and Welfare’s (MHLW) Pharmaceutical Safety and Environmental Health Bureau has reported its revisions of its safety guidance to ensure the safety of first-in-human (FIH) studies in drug development, by adding…
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