FDA’s Embrace of AI under Trump Administration
Under the Trump administration, the FDA is adopting artificial intelligence tools, with staff expressing concerns about their reliability. The agency announced the rollout of a large language model named Elsa, designed to assist various FDA personnel by expediting clinical protocol reviews, enhancing scientific evaluations, and prioritizing inspections. Elsa’s capabilities include summarizing adverse events for safety assessments, conducting quicker label comparisons, and generating code for nonclinical database development.
