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FDA Guides Sponsors On How To Update COVID-19 Products For Variants

By Kelly Lienhard / February 22, 2021 at 8:23 PM
FDA on Monday (Feb. 22) issued two new guidances and updated two existing guidances to guide COVID-19 test, vaccine and therapeutics developers on how to update their products to account for COVID-19 variants. The guidances, which were informed based on past experiences with infectious diseases like influenza and HIV, are part of the agency’s next step in addressing and mitigating the emerging COVID-19 mutations, the agency said. FDA has long prepared for possible variations to the SARS-CoV-2 virus, and it...


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