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FDA: COVID-19 Test Makers Should Apply For Full Authorization Now

By Kelly Lienhard / June 4, 2021 at 4:32 PM
FDA officials say manufacturers of COVID-19 tests that are on the market under emergency use authorization should begin submitting applications to convert their EUAs to full approval so they can stay on the market after the COVID-19 public health emergency is over. The agency has written and hopes to soon release a draft guidance that will guide sponsors through the EUA-to-approval conversion process. “Now is the time to be converting those submissions … if you want to stay on the...


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