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 ...

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 ...

On Thursday, shares in Charles River Laboratories, a leading contract research organizations that has stirred controversy over its use of non-human primates, plunged 28 percent after the FDA issued ...

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

Earlier this year, the medical device industry group AdvaMed protested when hundreds of probationary FDA employees funded ... be accompanied by policy and regulatory improvements that encourage ...

Credit: Saylakham / Shutterstock. The US Food and Drug Administration (FDA) has granted expanded 510(k) clearance for Epitel’s REMI Wireless electroencephalogram (EEG) System for neurological ...

who claims Americans’ food is packed with unsafe ingredients and chemicals—will not affect drug, medical device, or food reviewers or inspectors, HHS said. HHS said the cuts will likely be ...