The AP reported that the Trump administration's latest federal cuts have a significant effect on medical device regulation at ...

In the medical device industry, FDA inspections are not a regulatory hurdle — they are a powerful tool for improving product ...

Tech adoption might slow down if the FDA layoffs shift responsibility for medical device and AI safety to hospitals.

Health Canada recently published draft regulations to address therapeutic product shortages in Canada. The Regulations Amending Certain ...

As discussions intensify about how the second Trump administration will reshape the regulatory landscape for U.S.-based life sciences firms, ...

"Any place that gets cut, it's going to have an impact, because there's not any spare personnel at FDA,” said former agency ...

The Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) met on Tuesday to optimize the facilitated review pathway (FRP) to expedite access to essential ...

FDA Layoffs Shake Up Neuralink Trial Review Team. In a surprising move, the U.S. Food and Drug Administration (FDA) has laid off around 20 employees from its Office of Neurologica ...

The FDA and its Center for Devices and Radiological Health (CDRH) were among several health-focused agencies caught in ...

In particular, the cuts could hurt the FDA's efforts to scale up its expertise and review capabilities in emerging areas like digital- and AI-based devices.

On February 15, numerous probationary staff at FDA began receiving emails notifying them they had been fired. "Unfortunately, ...