Makary announced in May that he intended for the FDA to fully integrate generative AI into its work by the end of June; that ...

FDA announced on Dec. 1, 2025 that it will be providing agency staff with agentic artificial intelligence (AI) capabilities ...

Along with the deployment and integration the new agentic AI tool, FDA is also launching an agentic AI challenge for its ...

Agentic AI can help FDA staff manage meetings, conduct pre-market reviews and validate reports, among other tasks, though the ...

The agentic AI deployment will enable FDA staff to further advance the use of AI to assist with more complex tasks, such as meeting management, pre-market reviews, review validation, post-market ...

The FDA announced it will continue its speedy push into the AI unknown with new “agentic AI capabilities” to support a range ...

FDA rolls out agentic AI tools to assist staff with inspections, reviews, and compliance, enhancing workflow efficiency and oversight.

The FDA is offering staff a broad set of agentic AI tools despite concerns that the technology can behave unpredictably ...

The drive to roll out AI comes after sweeping job losses at the FDA that resulted from the cost-cutting drive implemented by Elon Musk and the now-defunct Department of Government Efficiency (DOGE), ...

The AHA is calling for a framework that balances innovation with appropriate safeguards to protect privacy and patient safety ...

"FDA’s talented reviewers have been creative and proactive in deploying AI capabilities — agentic AI will give them a powerful tool to streamline their work and help them ensure the safety and ...