There’s no questioning that AI should have governance and guardrails. As much good as it can bring, it also heightens risk.

Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is ...

The U.S. Food and Drug Administration has authorized the sale of Juul Labs' e-cigarette device and refill cartridges in ...

On July 22, 2025, the US Food and Drug Administration (FDA) started accepting applications to participate in the Commissioner’s National ...

Whoop pushed back on the warning letter, claiming its blood pressure feature for a wearable wristband is for “wellness” and ...

The FDA claims the wearable tech company's BPI offering is "adulterated" and "misbranded," and is being sold without the ...

Commissioner Marty Makary says the FDA will plow ahead with big plans on ultra process foods, dietary guidelines and ...

ClariMed, Inc., a global leader in human-centered medical device development and regulatory services, today announced it has ...

The U.S. Food and Drug Administration said on Tuesday it will now review all imports of the products it regulates regardless ...

As the threat of counterfeiting continues to torment industry stakeholders and patients, more strategic approaches to ...