The Food and Drug Administration launched a new tool intended to increase agency efficiency and streamline its processes.
The artificial intelligence tool, called Elsa, will “accelerate clinical protocol reviews, shorten the time needed for scientific evaluations, and identify high-priority inspection targets,” the FDA said, describing its assistance in reading, writing, and summarizing. “It can summarize adverse events to support safety profile assessments, perform faster label comparisons, and generate code to help develop databases for nonclinical applications,” the agency explained.
“Following a very successful pilot program with FDA’s scientific reviewers, I set an aggressive timeline to scale AI agency-wide by June 30,” FDA Commissioner Marty Makary stated. “Today’s rollout of Elsa is ahead of schedule and under budget, thanks to the collaboration of our in-house experts across the centers.”
Elsa is the agency’s first step in the FDA’s plans to integrate AI technology.
Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. celebrated the development, calling it a “revolution” for public health. “We’re building a faster, smarter, and more accountable HHS to Make America Healthy Again. Thank you, @DrMakaryFDA, for your leadership in driving this transformational change.”
The integration of AI tools follows President Donald Trump’s January executive order on the matter.
“It is the policy of the United States to sustain and enhance America’s global AI dominance in order to promote human flourishing, economic competitiveness, and national security,” the order says, urging the nation to “develop AI systems that are free from ideological bias or engineered social agendas.”
