Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
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US FDA Announces Draft Guidance for Simultaneous Development of Therapeutics and Companion Diagnostic Devices
The US FDA announced draft guidance on in vitro companion diagnostic devices (IVD companion diagnostic devices) on July 12, indicating the view that such devices should be developed at the same time as their corresponding therapeutic products in order to…
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