FDA’s AI assistant draws criticism over accuracy concerns
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Elsa, the FDA’s new AI assistant, has faced questions about its reliability, with internal reports describing occasional inaccuracies. While the Commissioner sees AI as a tool to improve FDA processes, some experts urge caution, noting that careful oversight is needed to ensure scientific and regulatory standards are maintained. The situation underscores the balance between adopting new technologies and preserving accuracy in public health decision-making.
Source
Makary MA, Prasad V. Priorities for a New FDA. JAMA. 2025;334(7):565–566. doi:10.1001/jama.2025.10116
Additional Reading
https://www.cnn.com/2025/07/23/politics/fda-ai-elsa-drug-regulation-makary