All IVD articles
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JournalEmergency use authorisation of in vitro diagnostic devices by the US FDA: The regulatory framework, lessons from COVID-19 and future directions
This article explores the FDA’s Emergency Use Authorisation framework and its aim to speed up the deployment of IVDs during public health emergencies, focusing on its evolution, operational mechanisms and significance in public health preparedness.
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JournalNavigating regulatory scrutiny: An analysis of requests for information in EU combined clinical trials
This article explores aspects of IVDR and how to implement these during clinical trial processes including submissions.