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Getting Started with the FDA’s New LDT Rule

Getting Started with the FDA’s New LDT Rule

by Michael Schubert, PhD | Jun 26, 2024 | Enforcement-lca, Essential, FDA-lca, Lab Industry Advisor, LDTs-lir, Top of the News-lir

Experts explain what the phase-in process will look like—and how labs can get ahead of the game.

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LDTs Around the World

LDTs Around the World

by Michael Schubert, PhD | Jun 4, 2024 | Enforcement-lca, Essential, Lab Industry Advisor, LDTs-lir, Legislation-lca, Top of the News-lir

Curious about how laboratory-developed tests are regulated in other countries? We compare in-house test guidance across six regions

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3 Thoughts on the FDA’s Final LDTs Rule

3 Thoughts on the FDA’s Final LDTs Rule

by Rachel Muenz | May 14, 2024 | News

Regulatory expert Julie Ballard shares her first thoughts on the final rule for lab-developed tests and immediate steps for labs

Special Analysis: Two Key Legislative Initiatives Labs Should Know About

Special Analysis: Two Key Legislative Initiatives Labs Should Know About

by Scott Wallask | Apr 3, 2024 | Elite, Lab Industry Advisor, Legislation-lca

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

FDA Watch: A New Blood Test for Accurate Alzheimer’s Detection

by Ron Shinkman | Mar 28, 2024 | Essential, FDA-lca, Lab Industry Advisor

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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