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To embed, copy and paste the code into your website or blog: FDA has been monitoring the emergence of novel coronavirus mutations and variants and their potential for impacting the results of currently authorized COVID-19 tests.   On February 22, FDA issued a new Guidance for COVID-19 test developers entitled “Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests: Guidance for Test Developers and Food and Drug Administration Staff.” The Guidance is designed to address the spread of several major variants carrying multiple mutations, the effects of the mutations on existing te...

Share this article Share this article SILVER SPRING, Md., Feb. 22, 2021 /PRNewswire/ -- Today, the U.S. Food and Drug Administration issued guidances for medical product developers, specifically covering vaccines, diagnostics and therapeutics products, to address the emergence and potential future emergence of variants of SARS-CoV-2, the virus that causes COVID-19. "The FDA is committed to identifying efficient ways to modify medical products that either are in the pipeline or have been authorized for emergency use to address emerging variants," said Acting FDA Commissioner Janet Woodcock, ...