Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
PMDA Announces Results of Pilot Study on Electronic NDA Submissions Using CDISC Standards
The Pharmaceuticals and Medical Devices Agency (PMDA) announced on March 27 the results so far of a pilot study being conducted to prepare for the introduction in FY2016 of electronic data submission using CDISC (Clinical Data Interchange Standards Consortium) standards,…
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REGULATORY
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