According to the U.S. Food and Drug Administration (FDA) website, the FDA will deploy "Agentic AI" capabilities for all employees to support more complex, multi-step workflows.
FDA Commissioner Marty Makary stated, "We are working to expand the application of artificial intelligence to provide our reviewers, scientists, and researchers with the best tools. This is a pivotal moment in the agency's history of modernizing with new technologies, and these new tools are expected to significantly enhance our ability to accelerate the delivery of therapies and treatments."
In May of this year, the FDA deployed Elsa, a tool based on LLM ( Large Language Model ). According to internal agency data, over 70% of employees voluntarily use the tool. Since its initial deployment, various business teams have continuously driven iterative optimizations of Elsa to better integrate it into their specific workflows.
The deployment of Agentic AI will enable FDA staff to further advance the use of AI to assist in handling more complex tasks, such as meeting management, premarket review, review and verification, postmarket surveillance, inspection and compliance, and administrative functions.
Jeremy Walsh, Chief Artificial Intelligence Officer at the FDA, stated: “The FDA’s outstanding reviewers have always been creative and forward-thinking in deploying AI capabilities, and Agentic AI will be an important tool for them to further streamline their workflows and enhance their ability to ensure the safety and effectiveness of regulated products.”
According to the FDA, the AI model runs in a high-security GovCloud (the US government's dedicated cloud platform) environment. The system does not use employee input data or data submitted by regulated industries to train the model, ensuring that sensitive research and regulatory data processed by FDA staff is not used for secondary learning. The agency views this deployment as another important step in its multi-dimensional AI strategy, pushing for deeper integration of artificial intelligence into daily workflows and improving operational efficiency.
Source: FDA
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