The FDA has qualified its first artificial intelligence tool to help drug developers evaluate fatty liver disease in their ...
FDA sought policy recommendations on mental health medical devices, including AI-enabled. After I reviewed submissions, one ...
Makary announced in May that he intended for the FDA to fully integrate generative AI into its work by the end of June; that ...
Along with the deployment and integration the new agentic AI tool, FDA is also launching an agentic AI challenge for its ...
The agency says agentic AI deployment will enable its staff to further advance the use of AI to assist with more complex ...
The agency’s sweeping rollout and staff challenge underscore rising momentum behind agentic AI: advanced, multiagent systems ...
The FDA has qualified the first AI-based drug development tool to support metabolic dysfunction-associated steatohepatitis clinical trials. The cloud-based tool, AI-Based Histologic Measurement of ...
The U.S. Food and Drug Administration (FDA) announced it is using various artificial intelligence tools to use in premarket reviews and for ...
December 1, 2025Sara Brenner, M.D., MPHPrincipal Deputy CommissionerU.S. Food and Drug Administration10903 New Hampshire Ave.Silver Spring, MD 20993Submitted ElectronicallyRE: FDA-2025-N-4203 Request ...
The drive to roll out AI comes after sweeping job losses at the FDA that resulted from the cost-cutting drive implemented by ...
FDA rolls out agentic AI tools to assist staff with inspections, reviews, and compliance, enhancing workflow efficiency and oversight.
The AHA is calling for a framework that balances innovation with appropriate safeguards to protect privacy and patient safety ...
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