Day: June 5, 2025

Last April, in what can only be described as a mic-drop moment for clinical laboratories, a federal judge in Texas struck down the FDA’s bold (and arguably baffling) move to reclassify laboratory-developed tests (LDTs) as medical devices. It was a legal slapdown decades in the making—and the FDA didn’t even bother to appeal. The deadline … Read more

The FDA just unveiled its own AI assistant, Elsa, designed to turbocharge safety reviews and regulatory workflows. But behind the polished launch is a growing debate: is Elsa a groundbreaking partner, or an overhyped experiment not ready for real work? The U.S. Food and Drug Administration has officially stepped into the AI era with the … Read more