A 60-day appeal window has passed for the Food and Drug Administration to appeal a federal court ruling that invalidated its ...

The FDA has opted to not appeal a federal court decision that struck down the agency’s rule to regulate laboratory-developed tests as medical devices. The 60-day window for appeal has passed, ...

Folks with cancer that has gene variants or rare diseases often need laboratory-developed tests for information that could guide their treatment when commercial tests don’t exist or aren’t ...

The Trump administration declined to appeal a court decision that ruled the FDA lacked the legal authority to regulate ...

The Food and Drug Administration’s attempt to increase regulatory scrutiny over laboratory developed tests appears to be dead, much to the relief of clinical labs. The FDA is unlikely to appeal ...

Judge Sean Jordan of the Eastern District of Texas struck down the FDA’s final rule that established the agency’s regulatory framework for ensuring the safety and effectiveness of laboratory ...

"This is a major victory for patients, as laboratory developed tests play an indispensable role in enabling patients to get timely diagnoses and care for conditions ranging from cancer to emerging ...