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

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

Many consumer devices undergo the FDA clearance process, such as LED masks and fitness trackers that have features like ...

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

Gottlieb, who led the FDA from 2017 to 2019, wrote that “recent changes to policies related to the regulation of AI have ...

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

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 ...

Nasal vaccine devices have the potential to offer more convenient and more effective protection against a variety of viruses.

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

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 ...