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FDA: EUAs for COVID-19 Lab Tests Will Continue after PHE Ends

by Glenn S. Demby | Feb 13, 2023 | Essential, FDA-nir, National Lab Reporter

Agency says it will continue to have authority to clear new lab tests and other COVID-19 products on an emergency basis even after the PHE ends.

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End of Public Health Emergency Won’t End COVID-19 EUAs

End of Public Health Emergency Won’t End COVID-19 EUAs

by Glenn S. Demby | Feb 8, 2023 | News, Open Content

FDA will still be able to issue EUAs for COVID-19 tests after May 11.

FDA Watch: 2022 510(k) Lab Test Approvals Year in Review

FDA Watch: 2022 510(k) Lab Test Approvals Year in Review

by Glenn S. Demby | Jan 31, 2023 | Essential, FDA-lir, Laboratory Industry Report

Abbott and Roche garnered the lion’s share of new 510(k) lab test approvals in 2022.

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Roche Scores First European IVDR Approval for Diagnostic Tests

by Glenn S. Demby | Jan 26, 2023 | Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, FDA-dtet

The test manufacturer is the first to gain IVDR certification for a companion diagnostic under the new regulation.

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Roche Alzheimer’s Early Detection Tests Get FDA Green Light

by Glenn S. Demby | Dec 22, 2022 | Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, FDA-dtet

In this month’s diagnostics pipeline report, Roche gets clearance for two new Alzheimer’s early detection tests.

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