One attorney said the ruling “isn’t quite the stake in the heart.” The FDA is unlikely to challenge the court’s decision, but ...

The question is not whether AI will transform healthcare; it’s whether regulators can keep pace with that transformation.

On Monday, March 31, a court in the Eastern District of Texas found unlawful and vacated the Food and Drug Administration’s ...

In another rebuke to federal regulatory overreach, the U.S. District Court for the Eastern District of Texas (“District Court”) has vacated the ...

HHS Secretary Robert F. Kennedy Jr.’s sweeping layoffs across federal health agencies are disrupting the work of drug, ...

Artificial intelligence has become one of the most transformative forces in health care, reshaping everything from drug discovery to diagnostics.

The agency could continue to pursue more extensive LDT oversight by tightening control over items like RUO reagents and specimen collection devices.

MINNEAPOLIS — U.S. Food and Drug Administration approvals of life-changing, high-risk medical devices reportedly slowed to a ...

Less regulation was also the focus of committee chair Rep. James Comer (R-Ky.). "The Biden administration stifled innovation ...

The US FDA is coping with a series of Trump-imposed job cuts. These are starting to hamper food safety and pharmaceutical ...

The rise of AI in health care presents new challenges related to the patentability and regulation of AI-driven medical ...

A Neuralink rival backed by a former collaborator of Elon Musk has just received FDA clearance for its brain implant.