Agentic AI can help FDA staff manage meetings, conduct pre-market reviews and validate reports, among other tasks, though the agency emphasized that using this technology is optional for its employees.
The FDA is deploying agentic AI models to streamline tasks, continuing Commissioner Marty Makary’s campaign to “modernize” the agency.
As its name suggests, agentic AI makes use of machine learning “agents,” IBM explains, using models that solve complex problems by simulating human problem-solving. In its press announcement on Monday, the FDA noted the capability of agentic AI for “planning, reasoning, and multi-step actions,” making use of specific guidelines, including human oversight, to produce certain outcomes.
For agency staff specifically, agentic AI will assist with managing meetings, conducting pre-market reviews and post-market surveillance and validating reviews, while also helping with inspections and other administrative functions.
Agentic AI is “entirely optional” for employees, the regulator said, however noting that to help with uptake, the FDA will hold an Agentic AI Challenge during which employees can build agentic solutions for unspecified problems. The contest will run for two months, with outputs to be presented in January.
“We are diligently expanding our use of AI to put the best possible tools in the hands of our reviewers, scientists and investigators,” Makary said in a prepared statement on Monday, noting that the agency is well-positioned to “modernize with tools that can radically improve our ability to accelerate more cures and meaningful treatments.”
The agentic AI initiative comes after the FDA in June launched its generative AI tool Elsa, likewise in a bid to improve the efficiency of its staffers. Elsa assists with “reading, writing, and summarizing,” the regulator explained at the time, adding that employees can use it to assess products’ safety profiles, compare drug labels more quickly and create databases for non-clinical applications.
Elsa also allows for faster protocol reviews and scientific evaluation, as well as helping employees identify high-priority tasks.
Both Elsa and the new agentic AI program operate within a secure cloud environment and have no access to data from the regulated industry, according to the FDA.
