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Mintz - Health Care Viewpoints

Five Observations from FDA’s Responses to Comments in the Final Rule on LDTs

Mintz - Health Care Viewpoints on

Now that the final rule on laboratory developed tests (LDTs) has been available for over a month and the stages of the enforcement discretion phaseout process and the Food and Drug Administration’s (FDA’s) newly proposed...more

Paul Hastings LLP

A Sea Change Looms as FDA Finalizes Its Controversial Regulation Asserting Jurisdiction Over LDTs

Paul Hastings LLP on

On April 29, 2024, after years of false starts trying to expand oversight of laboratory developed tests (“LDTs”) through administrative and legislative actions, FDA announced the much-anticipated—and highly...more

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