Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
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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