FDA rushed out agency-wide AI tool—it’s not going well
Under the Trump administration, the Food and Drug Administration is eagerly embracing artificial intelligence tools that staff members are reportedly calling rushed, buggy, overhyped, and inaccurate.
On Monday, the FDA publicly announced the agency-wide rollout of a large language model (LLM) called Elsa, which is intended to help FDA employees—"from scientific reviewers to investigators." The FDA said the generative AI is already being used to "accelerate clinical protocol reviews, shorten the time needed for scientific evaluations, and identify high-priority inspection targets."
"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 announcement promised.