3 Thoughts on the FDA’s Final LDTs Rule
Regulatory expert Julie Ballard shares her first thoughts on the final rule for lab-developed tests and immediate steps for labs
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Special Analysis: Two Key Legislative Initiatives Labs Should Know About
Though potential FDA LDTs regulation has drawn a lot of attention, other efforts could also have long-term effects on how labs do business.
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FDA Watch: A New Blood Test for Accurate Alzheimer’s Detection
The ALZpath DX assay is less invasive than other diagnostic tests, and may give patients diagnosed with Alzheimer’s more time to plan
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Year in Review: The 8 Most Important Lab Compliance Stories of 2023
Though things appeared status quo in 2023, last year may prove to be a turning point for the laboratory industry.
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The Future of Laboratory-Developed Tests
Comments on the FDA’s proposed rule to regulate LDTs as in vitro diagnostic devices reveal mixed reactions.
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