Archives of pathology & laboratory medicine
Challenges in Structuring SARS-CoV-2 Emergency Use Authorization Diagnostics Data: Leveraging Findable, Accessible, Interoperable, and Reusable Principles for the Next Era of Diagnostic Data Transparency.
Alexander J Phillips, Aaron L Glieberman, Christina Gallegos, Anthony Morrison, Michael R Reed, Veronique T Baron, Karthik Dinakar, Anna Borchers, Faten A Okda, Webb Stone, Sujeewa Sampath Lellupitiyage Don, Stephanie N Ishack, Sameer V Rajesh, Richard S Creager, Samantha Bates Weinstock
Published: 202510.5858/arpa.2025-0144-OA
Abstract
Context.—: The US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for SARS-CoV-2 assays encompassed both in vitro diagnostic and laboratory-developed tests. Related testing data and documents from EUAs were published on the FDA w…
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