Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
REGULATORY
PMDA Plans Manufacturing Inspections for 2 Regenerative Medicine Products This Year
The Pharmaceuticals and Medical Devices Agency (PMDA) plans to conduct manufacturing practice inspections by the end of this year for two regenerative medicine products filed for approval under the Pharmaceuticals and Medical Devices Law, a PMDA official said on February…
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Related LEXICON
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Conditional, Time-Limited Approval条件・期限付き承認January 29, 2015
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