The US Food and Drug Administration (FDA) is cautioning patients and caregivers about the potential for not receiving blood ...

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

Tazbaz was director of the FDA’s Digital Health Center of Excellence for two years, leading key policies on artificial intelligence and software as a medical device.

The Cybersecurity and Infrastructure Security Agency and Food and Drug Administration Jan. 30 released notices warning of ...

The FDA’s framework for AI regulation, while robust for premarket evaluation, would benefit from more specific mechanisms for continuous monitoring of AI performance in diverse real-world settings.

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

The new director of the FDA’s device center contrasted a European rule with the lack of mandatory reporting requirements for ...

Instructions for filling out the medical device establishment licence application. Information includes a calculation chart for the required fees and related guidance documents.

Meanwhile, other countries continue to allow Red Dye No. 3 in certain applications, meaning imported foods must comply with U.S. regulations upon entry . The FDA's decision to ban Red Dye No. 3 ...

“Our consumers and everyone in the food industry want and expect a strong FDA, and a consistent, science-based national regulatory framework. We have been saying for years that FDA is the ...