Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
PMDA Issues Guidance on COVID-19 Vaccines’ Immunogenicity Assessment for Non-Placebo-Controlled Trials
The Pharmaceuticals and Medical Devices Agency (PMDA) on October 22 issued guidance on the implantation of confirmatory clinical trials without placebo groups to develop new COVID-19 vaccines, detailing points to bear in mind when evaluating efficacy based on immunogenicity-related markers.…
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