InvestorNewsBreaks – FDA Accelerates Launch of AI Tool Elsa, Raising Questions on Transparency and Oversight
The U.S. Food and Drug Administration (“FDA”) has fast-tracked the rollout of its AI tool, Elsa, originally planned for June 30, with Commissioner Dr. Marty Makary touting the launch as both “ahead of schedule and under budget.” Elsa is already streamlining workflows across the agency, reducing multiday review tasks to minutes, and handling administrative functions such as safety profile assessments, label comparisons, and protocol reviews.…