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FDA Updates COVID-19 Test Policy; Asks Developers To Seek Premarket Review Pathways

Por: RTTNews Health September 28, 2022

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The U.S. Food and Drug Administration said it now intends to review only a small subset of new emergency use authorization or EUA requests for diagnostic tests.As per an updated COVID-19 test policy with a view to ensure continued access to tests, the regulator further urged developers of all test types seeking marketing authorization to pursue traditional premarket review for most test types.The policy change seeks the transition of these... + full article



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