Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
PMDA Opens New Office to Prepare for Introduction of CDISC Standards
The Pharmaceuticals and Medical Devices Agency (PMDA) established a new office on April 1 in order to prepare for the introduction in FY2016 of electronic submissions of clinical data with electronic new drug applications (eNDAs) using CDISC (Clinical Data Interchange…
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REGULATORY
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