Sources: 1
The U.S. Food and Drug Administration (FDA) has officially launched Elsa, a generative Artificial Intelligence (AI) tool, across the entire agency to improve efficiency in clinical reviews and scientific evaluations.
Elsa was initially piloted with FDA scientific reviewers, yielding successful results that prompted Commissioner Marty Makary, M.D., M.P.H., to set an "
aggressive timeline to scale AI agency-wide by June 30."
The AI tool is already being utilized to "
accelerate clinical protocol reviews, shorten the time needed for scientific evaluations, and identify high-priority inspection targets." This marks a significant step in the FDA's broader AI strategy.
"The introduction of Elsa is the initial step in the FDA's overall AI journey," the agency stated, with plans to expand AI integration into other processes such as data processing and generative AI functions to further support its mission.
By leveraging Elsa, the FDA aims to streamline workflows for employees ranging from scientific reviewers to investigators, enhancing the agency's ability to evaluate and regulate medical products more efficiently.
This move reflects the FDA's commitment to adopting cutting-edge technology to improve public health outcomes and regulatory effectiveness.
Key quote: "Following a very successful pilot program with FDA's scientific reviewers, I set an aggressive timeline to scale AI agency-wide by June 30," said FDA Commissioner Marty Makary, M.D., M.P.H.
Key stats: Elsa is currently accelerating clinical protocol reviews and shortening scientific evaluation times, with plans for broader AI integration ahead.
Sources: 1
The FDA has launched Elsa, a generative AI tool, agency-wide to enhance efficiency in clinical protocol reviews and scientific evaluations. Following a successful pilot, Commissioner Marty Makary aims to scale AI use by June 30, marking the start of broader AI integration in FDA processes.
