FDA Watch: How Could the End of Chevron Impact the FDA and LDTs?
A lawsuit by a group of herring fishermen upended 40 years of legal precedent regarding how federal agencies interpret statutes
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Getting Started with the FDA’s New LDT Rule
Experts explain what the phase-in process will look like—and how labs can get ahead of the game.
LDTs Around the World
Curious about how laboratory-developed tests are regulated in other countries? We compare in-house test guidance across six regions
The Future of Laboratory-Developed Tests
Comments on the FDA’s proposed rule to regulate LDTs as in vitro diagnostic devices reveal mixed reactions.
Final Rule Clarifies Liability for Off-Label Uses and Lab’s Right to Create LDTs
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Cloud-Based Platform Enlists Quest to Provide COVID-19 Molecular Test Results to Travelers
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Congress Reintroduces Rival VALID and VITAL Acts to Regulate New Lab Tests
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Manufacturers Wait Anxiously for CMS Decision on Automatic Medicare Coverage of MCIT Breakthrough Devices
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AMA Creates New PLA Code 0247U for Sera Prognostics PreTRM Test
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Abbott and Quidel Stake Out Early Claims for Leadership of SARS-CoV-2 Rapid Antigen Testing Market
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FDA Offers New Guidance on Validating SARS-CoV-2 Tests in “Non-Laboratory” Settings
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FDA Watch: Lab Industry Objects to Agency’s New LDT Proposal
From - Laboratory Industry Report
On Aug. 3, the Food and Drug Administration heated the long simmering controversy over FDA regulation of laboratory developed tests (LDTs) to full boil by submitting…
Kellison Award goes to FDA’s Dr. Alberto Gutierrez
From - Laboratory Industry Report
Dr. Alberto Gutierrez is the 2017 recipient of the Kellison Lab Industry Distinguished Service Award. Dr. Guitierrez retired in August after…