Are Concessions In FDA's Lab-Developed Tests Rule Enough?

By Dominick DiSabatino and Audrey Mercer (May 8, 2024, 6:56 PM EDT) -- On April 29, the U.S. Food and Drug Administration issued a highly anticipated — and highly controversial — final rule that rolls out a four-year, five-stage plan that will phase out the agency's previous policy of enforcement discretion for laboratory-developed tests, or LDTs....

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