Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
RWD Use in Regulatory Submissions Could Start with Rare Diseases: PMDA Chief
The envisaged use of real-world data (RWD) in regulatory submissions would be first seen in limited areas such as rare diseases including rare cancers, Yasuhiro Fujiwara, chief executive of the Pharmaceuticals and Medical Devices Agency (PMDA), said on September 6.…
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