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Navigating the FDA’s Revised Authorization and Ensuring a Seamless Transition from Emergency-Use-Labeled Paxlovid to Approved Labeling

In December 2021, the US Food and Drug Administration (FDA) granted an emergency use authorization (EUA) for Pfizer's novel antiviral drug Paxlovid, ushering in a new tool for managing severe COVID-19 cases in individuals with a high risk of serious illness. By May 2023, the FDA had further validated Paxlovid's efficacy by approving its new…

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