FDA Unveils AI Tool Named Elsa

The FDA recently announced the launch of its artificial intelligence tool, named Elsa, which is designed to enhance efficiency in various agency functions. Elsa utilizes a large language model to assist FDA employees by summarizing adverse events, facilitating label comparisons, and generating code for database development in nonclinical applications. The tool operates in a secure GovCloud environment to protect sensitive data and is already being employed to expedite clinical protocol reviews and streamline scientific evaluations. FDA Commissioner Marty Makary emphasized the successful pilot program that led to Elsa’s early rollout, and Jeremy Walsh, the FDA’s first chief AI officer, highlighted its potential to transform employee performance. The introduction of Elsa marks the beginning of a broader AI initiative, with plans for further integration of AI technologies in the FDA’s processes to better fulfill its mission and adapt to employee needs.

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