Japan is considering a new approach to its “special” market expansion re-pricing that would exclude drug sales tied to private…
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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