Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration ...

The Food and Drug Administration (FDA) has formed a task force assigned to improve regulation of medical devices in the ...

FDA Medical Device Regulation Over the Use of AI in Clinical Trials As FDA noted in the JAMA article, artificial intelligence and machine learning (AI/ML) have many potential uses in clinical ...

Gottlieb, who led the agency during the first Trump presidency, supports a reversion to an earlier interpretation of the 21st Century Cures Act.

2024 was a critical year for the FDA’s Center for Devices and Radiological Health and included a smooth transition in leadership, but it was not without controversy. The agency triggered not one but ...

The FDA today issued a safety communication relating to certain diabetes devices that connect to smartphones.

Tazbaz was director of the FDA’s Digital Health Center of Excellence for two years, leading on policies involving artificial ...

Following a recall of grounding pads produced by Megadyne, a machinery industry company, the FDA is notifying veterinarians ...

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