JD Supra

FDA Reverses Final Rule on LDTs: A Win for Labs, a Shift in Regulatory Strategy

In a major regulatory reversal, the U.S. Food and Drug Administration (FDA) has officially rescinded its 2024 final rule that sought to regulate Laboratory Developed Tests (LDTs) as medical devices.
JD Supra

FDA Reverses Final Rule Regulating Laboratory Developed Tests

The United States Food and Drug Administration (FDA) has officially rescinded its final rule proposing to regulate Laboratory Developed Tests (LDTs) as medical devices. On Sept. 19, 2025, FDA issued a ...
Healthcare Dive

Could the FDA take an indirect approach to regulate LDTs?

When the deadline to appeal the court decision that blocked the Food and Drug Administration’s final rule regulating laboratory developed tests as medical devices slipped by in May without a word from ...
Atlanta Journal-Constitution

Georgia judge scraps FDA rule for cigarette packaging

The U.S. Food and Drug Administration’s latest rule requiring graphic warnings on cigarette packaging and advertising has been tossed out by a federal judge in South Georgia. In a written order Friday ...
The National Law Review

FDA Delaying Enforcement (Again) for Menu Labeling Final Rule

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...