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Articles tagged with “fda-ai-submissions”

How Many FDA Submissions Use AI? CDER's Review Findings

Analysis of CDER's disclosed AI submission counts from 2016 to 2026, the January 2025 AI credibility guidance, the Elsa review tool, and named case studies as of August 2026.

33 min read

8/1/2026

fda ai submissions cder artificial intelligence ai drug development fda ai guidance ai regulatory submissions fda elsa ai tool ai drug discovery machine learning fda ai medical devices fda cder ai review process