Next Steps: With LDT Final Rule Now Null, Industry Groups Urge Lab Managers and Pathologists to Advocate for Change
CAP and AMP officials weigh in on plans to push for a legislative- or CLIA-based approach to future LDT oversight
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LDT Appeal: Looking at the Legal Nuances Behind Potential FDA Actions Following Court Decision
Marginal LDT scenarios could be where the FDA focuses on next, a lawyer notes
LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
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…
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