News Archive—September 2024

NYSCLA Alert to Laboratories (September 2024)

FDA’s Final Rule Regulating LDTs

On May 6, 2024, the Food and Drug Administration (“FDA”) issued its long-anticipated final rule regulating laboratory developed tests (“LDTs”). In the May 6, 2024 final rule, the FDA outlined several categories of full and partial enforcement... Read more

Sep 3 2024