Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
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ICH Reaches Agreement to Treat Subjects with Similar Ethnic Factors as Single Populations Regardless of Nationality
The International Council for Harmonization (ICH) agreed to include an idea of “pooled populations” in its E17 Guideline (Multi-Regional Clinical Trials) at its meeting in Jacksonville, Florida, an official of the Pharmaceuticals and Medical Devices Agency (PMDA) said in a…
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