Articles tagged with “context-of-use”

FDA's AI Guidance: 7-Step Credibility Framework Explained

Learn about the FDA's AI guidance for drug development. This article explains the 7-step credibility framework, context of use (COU), and risk-based approach.

50 min read

1/2/2026

fda guidance ai in drug development credibility framework regulatory affairs model validation context of use risk-based approach biologics regulation machine learning