Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
ORGANIZATION
Adoption of CDISC Standards Will Be Daunting Task: JPMA Regulatory Affairs Head
As Japan plans to make electronic clinical data submissions mandatory sometime in FY2016, it is expected to be painstaking work for big pharmas to adjust their systems to clinical data interchange standards consortium (CDISC) standards – a new format the…
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ORGANIZATION
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