FDA Watch: How Could the End of Chevron Impact the FDA and LDTs?
A lawsuit by a group of herring fishermen upended 40 years of legal precedent regarding how federal agencies interpret statutes
A lawsuit by a group of herring fishermen upended 40 years of legal precedent regarding how federal agencies interpret statutes
Experts explain what the phase-in process will look like—and how labs can get ahead of the game.
The ALZpath DX assay is less invasive than other diagnostic tests, and may give patients diagnosed with Alzheimer’s more time to plan
G2’s list of major FDA approvals includes cancer and liquid biopsy, COVID-19, STI, and neurologic tests.
Comments on the FDA’s proposed rule to regulate LDTs as in vitro diagnostic devices reveal mixed reactions.
With US STI cases continuing to climb to numbers not seen in decades, a recent FDA approval comes at an opportune moment.
Performing your own audit to verify compliance and identify problems is one key to achieving a successful FDA audit.