What Is FDA Emergency Use Authorization?

As companies announce the marketing or development of diagnostic tests for the new coronavirus, they invariably reference an Emergency Use Authorization, or EUA.U.S.-based Co-Diagnostics Inc (NASDAQ: CODX) announced April 6 that its Logix Smart SARS-CoV-2 test received an EUA from the FDA, sending its shares higher by about 26%.What Is EUA? An EUA is accorded by the FDA under section 564 of the Federal Food, Drug and Cosmetic Act. It allows unapproved medical products or unapproved uses of approved medical products to be used in an emergency for diagnosing, treating or preventing serious or life-threatening diseases or conditions, especially …read more

Source:: Yahoo Finance

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