With great fanfare, the US Food and Drug Administration (FDA) on 2nd June 2025 announced the agency-wide rollout of its new artificial intelligence (AI) scientific review assistant, Elsa. The launch, FDA commissioner Marty Makary proudly explained, took place almost a month ahead of schedule, with the tool having already proven helpful in significantly streamlining staff workflows.
However, mixed feedback on its results has raised questions about the tool’s readiness and performance capabilities.
