Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
PMDA to Conduct Pharmacokinetic Analysis in Pilot Study on Electronic NDA Submissions
An executive member of the Pharmaceuticals and Medical Devices Agency (PMDA) said on March 28 that the PMDA will conduct a pharmacokinetic analysis in a FY2014 pilot study on the submissions of electronic new drug applications (eNDAs). To do so,…
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