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. The tool is housed in a secure GovCloud environment and was not trained on industry-submitted data, according to Makary.
Still, the launch has raised questions about transparency, validation, and long-term oversight. Some FDA staff reportedly viewed the rollout as rushed, potentially linked to recent workforce cuts. Regulatory and legal experts have called for public disclosure of how Elsa was trained and tested, warning that AI-influenced decisions could complicate future disputes. Despite concerns, many in the biopharma space welcomed the move, noting it aligns with broader industry trends toward AI-driven efficiency in drug development.
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