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Evidence Explorer · EV-020

AI in drug development

FDA reports significant growth in drug application submissions that include AI components across the drug-development lifecycle.

E596/100 confidenceFederal regulatory trend

What this evidence supports

FDA CDER reports increasing use of AI across drug-development submissions.

What it does not establish

FDA's statement describes submission trends, not a blanket endorsement of specific AI methods or outputs.

Record details

Source authority: FDA CDER
Evidence level: E5
Directness: 5/5
Recency: 4/5
Decision relevance: 5/5
Date: 2026-05-01

Primary source

https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/artificial-intelligence-drug-development

Related intelligence

FDA reports increasing use of AI across the drug-development lifecycle