ACLA Sues FDA Over Regulation of Laboratory-Developed Tests—in Texas
The choice of venue was likely inspired by the longstanding anti-regulatory stance of the state's federal judges.
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New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
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.
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LDTs Around the World
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
Regulatory expert Julie Ballard shares her first thoughts on the final rule for lab-developed tests and immediate steps for labs