Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
PFSB Issues Director Notification Calling for Revision of Package Inserts for Products Including Kiklin, Stivarga
The Pharmaceutical and Food Safety Bureau’s (PFSB) Safety Division issued a director notification to the Federation of Pharmaceutical Manufacturers’ Associations of Japan (FPMAJ) on February 18 calling for the revision of package inserts for the hyperphosphatemia treatment bixalomer (Astellas Pharma’s…
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REGULATORY
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