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Expert Analysis

The Regulatory Headwinds Facing Lab-Developed Tests

By Kate Hardey, Caitlin Kierum and Tasha Gerasimow (August 20, 2024, 2:42 PM EDT) -- On May 6, the U.S. Food and Drug Administration published its final rule regarding laboratory-developed tests, which modified the FDA's previous policy of exercising enforcement discretion toward LDTs.[1]...

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