Key Takeaways From FDA Final Rule On Lab-Developed Tests

By Michele Buenafe and Dennis Gucciardo (May 14, 2024, 3:19 PM EDT) -- The U.S. Food and Drug Administration on April 29 announced its final rule on laboratory-developed tests. This move marks the beginning of the end of the FDA's broad and long-established enforcement discretion policy for tests, which are known as LDTs and are mostly not expected to meet the premarket or post-market regulatory requirements....

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