ELSA: The U.S. FDA's Generative AI Initiative – 33 Important Q&A for Drug Developers

The U.S. Food and Drug Administration (FDA) has launched a new internal generative AI tool, ELSA (Enterprise Language Support Assistant), marking a significant step in its technological modernization. This document delves into the initiative, exploring the technology behind ELSA, its intended applications, the early challenges reported since its deployment in June 2025, and its broader implications for the agency and its stakeholders.

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