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

The Food and Drug Administration’s (FDA) recent rejection of all study data from Mid-Link Testing highlights the importance of using reliable, ...

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 ...

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 ...

WASHINGTON—This week, thirteen national advocacy groups concerned about public health, environment, and animal welfare urged key federal agencies to maintain regulatory authority over genetically ...