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FDA Issues New Directions For Submitting Approval Requests To Companies Making At-Home Coronavirus Tests

  • July 30, 2020

Bloomberg Law (7/29, Alexander, Subscription Publication) reports “companies making at-home [COVID-19] tests got new directions from the FDA Wednesday on submitting their tests for approval under emergency use conditions.” The agency’s “template is intended to help get simple at-home or over-the-counter diagnostic tests on the market, comparable to home pregnancy tests, according to FDA Commissioner Stephen M. Hahn.”
      USA Today (7/29, Weintraub, Alltucker) also reports.