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FDA Policy on Viral Mutations: Overview FDA

FDA Policy on Viral Mutations: Overview

The article describes the approach to be applied with respect to viral mutations and their potential impact on the performance of tests intended to identify the virus. Table Of Contents: The Food and Drug Administration (FDA or the Agency), the US regulating authority...

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MDCG Guidance on EUDAMED Alternatives MDCG

MDCG Guidance on EUDAMED Alternatives

The Medical Device Coordination Group (MDCG), an advisory body of the European Commission comprised of the representatives of all Member States, has published a guidance document dedicated to harmonized administrative practices and alternative technical solutions...

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