The U.S. Food and Drug Administration (FDA) has revealed recommendations for drug developers and diagnostic test makers to address the efficacy and overall performance of their products in consideration of the COVID-19 variants. The updates in recommendations are across four guidances regarding diagnostic tests, monoclonal antibodies, vaccines, and drugs and biologics. During a press conference, Acting FDA Commissioner Janet Woodcock stated, “The purpose of these guidances 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 guidances 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 EUA products to address these variants.”
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