Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
PMDA Eyes Mandatory Electronic Filings for NDA Clinical Trial Data from FY2016
The Pharmaceuticals and Medical Devices Agency (PMDA) intends to require drug makers to submit clinical trial data for their new drug applications (NDAs) in electronic formats, beginning in FY2016—a move that would allow the authority to efficiently store and analyze…
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REGULATORY
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