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FDA Releases New Guidance for Covid-19 Products

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At the beginning of this week the FDA unveiled four new and updated guidance targeting vaccines, drugs and biologics, monoclonal antibodies and diagnostic tests. to address the impact of COVID-19 variants on the efficacy and performance of their products. In a recent article, acting FDA Commissioner Janet Woodcock is noted as saying “[t]he purpose of these guidance is to address the emergence and potential future emergence of variants of SARS-CoV-2, the virus that causes COVID-19. The reason for these guidance is any of these products might be impacted by changes to the virus, particularly their efficacy or performance. Therefore, we need to identify efficient ways to modify the products that are either in the pipeline or are [emergency use authorization] EUA products to address these variants.” More to follow on the substance of the updated guidance documents. Stay tuned….. #FDA #lifesciences #Covid