FloodLAMP FDA Internal Use of AI -- Developments in Using AI to Improve Review Speed, Quality, and Consistency
Report on FDA's internal adoption of generative AI tools -- including the "Elsa" platform and the 2025 AI-assisted scientific review pilot -- to improve the speed, quality, and consistency of regulatory review workflows across CDRH and other centers. Covers stated capabilities, data separation commitments, transparency gaps, and implications for regulated industry.
ai
file
regulatory
fda-townhalls
_AI_FDA_Internal_AI_Use_Report.md
regulatory/fda-townhalls/_AI_FDA_Internal_AI_Use_Report.md
2026_03_01
Created by Claude (claude-4.6-opus) during archive preparation. **NOT HUMAN VERIFIED - MAY CONTAIN ERRORS** Report on FDA's internal adoption of AI/GenAI tools to improve review speed, quality, and consistency. Derived by extracting and refocusing the internal-use content (Track B) from a broader AI+FDA diagnostics report originally produced by an external AI tool. Key sources include FDA press releases on the AI review pilot and Elsa launch, and the CDRH 2025 Annual Report.
fda, ai, internal-ai, review-process, elsa, genai
md
CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/
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