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

With the introduction of genAI tool Elsa at the FDA in June, the technology is playing a greater role in the medical device review process.

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

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

The Drug Regulatory Authority of Pakistan (Drap) on Tuesday directed three pharmaceutical companies to recall “substandard” ...

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 ...

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

David King of Samsung Biologics shares insights on market demand and the technologies and capabilities needed to support ...

A dozen lawsuits have been filed over spinal cord stimulators, which are medical devices surgically implanted to reduce chronic back pain. The suits name device manufacturers, such as Abbott and ...