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

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

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

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

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

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

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

The division is canceling all planned activities, including scientific and regulatory education ... to the two FDA employees.

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

Federal data show the regulatory agency—which has fired ... "The reduction did not affect drug, medical device, or food reviewers, nor impacted inspectors. The critical work will continue." ...