The industry’s heavy reliance on waterfall project management has resulted in long, siloed, and high-risk product development ...

On March 31, 2025, the Eastern District of Texas issued a decision in the case brought by the American Clinical Laboratory Association (ACLA) and ...

U.S. Food and Drug Administration Commissioner Martin Makary announced on Thursday a policy to limit employees of companies ...

Two former FDA leaders look at Commissioner Marty Makary’s early stumbles — and lay out a list of priorities to protect both ...

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

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

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.

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