Health Law Diagnosed – A Discussion on the Regulatory Requirements for LDTs
Lexology March 7, 2024
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In this episode of Health Law Diagnosed, host Bridgette Keller is joined by Mintz Health Law attorneys Joanne Hawana and Benjamin Zegarelli to discuss the FDA’s long-awaited proposed rules that actively regulate laboratory developed tests (LDTs). LDTs have historically not been subject to significant regulatory oversight, and while the FDA aims to promptly release the...