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Congress Retables VALID and VITAL Legislation to Regulate LDTs

By Glenn S. Demby | Aug 5, 2021 | 1 min read

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FDA Pulls the Plug on EUA Review of COVID-19 LDTs

By Glenn S. Demby | Nov 2, 2020 | 1 min read

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Agency Stripped of Authority to Issue Premarket Approval of SARS-CoV-2 LDTs

By Glenn S. Demby | Sep 9, 2020 | 1 min read

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FDA Cracks Down on Improper Marketing of SARS-CoV-2 Antibody Tests

By Glenn S. Demby | Aug 4, 2020 | 1 min read

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Agency to Use EUA Pathway to Clear New Coronavirus Detection Tests

By Glenn S. Demby | Jan 30, 2020 | 1 min read

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Lab Companies Scramble to Bring Coronavirus Detection Tests to Market

By Glenn S. Demby | Jan 30, 2020 | 1 min read

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FDA Extends Deadline to Comment on Proposed 510(k) Pathway Reform

By Glenn S. Demby | Apr 22, 2019 | 1 min read

From - Lab Compliance Advisor
April 22, 2019 was supposed to the last day to comment on newly proposed FDA guidance on changing the Section 510(k) premarket review process for…

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Compliance Alert: FDA Warning Letter to Inova Genomics Laboratory

By Glenn S. Demby | Apr 15, 2019 | 1 min read

By Danielle Sloane bio and Elaine Naughton bio
Despite it being a continual topic of discussion, the Food and Drug Administration ("FDA") enforcement in the realm of laboratory developed tests…

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From DAIA to the VALID ACT: The Latest Chapter in FDA Diagnostic Test Oversight Reform

By Glenn S. Demby | Jan 28, 2019 | 1 min read

From - Lab Compliance Advisor
While FDA oversight over new diagnostic tests is perfectly acceptable, what is objectionable is the…

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Government Shutdown: The Impact on the Agencies that Regulate Labs

By Glenn S. Demby | Jan 23, 2019 | 1 min read

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LDTs, FDA-Approved Companion Diagnostics Perform Similarly; Off-Label Use of Companion Diagnostic Kits Common

By Glenn S. Demby | Jan 3, 2018 | 1 min read

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FDA Warns About Biotin Interference With Lab Tests

By Glenn S. Demby | Jan 3, 2018 | 1 min read

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CLIA Corner: FDA Moves to Boost CLIA Waiver Transparency

By Glenn S. Demby | Nov 30, 2017 | 1 min read

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