Articles tagged with “context-of-use”

EMA NAM Data Pilot: Eligibility and Evidence Readiness

A 2026 guide to EMA NAM pilot eligibility, four regulatory applicability areas, pathway selection, Module 2.4 package design, and evidence-readiness scoring.

30 min read

9/19/2026

ema nam pilot ema voluntary data submission new approach methodologies nam briefing package regulatory applicability areas context of use evidence readiness ectd module 2.4 toxicology

FDA Draft Guidance on AI in Drug Development Explained

Examine the January 2025 FDA draft guidance on AI in drug development. This report details the 7-step credibility framework and excluded AI applications.

65 min read

4/1/2026

fda draft guidance ai drug development credibility framework context of use pharmaceutical regulation regulatory submissions fda ai policy

FDA AI Credibility Framework: Impact on Research Tools

Analyze the FDA AI Credibility Framework and its impact on scientific research tools. Review the 7-step risk-based validation process for drug development.

40 min read

3/8/2026

fda ai credibility framework ai in drug development scientific research tools risk-based validation context of use regulatory compliance life sciences ai

FDA AI Credibility Assessment in Drug Development

Review the FDA's 7-step AI credibility assessment framework. Understand how to validate and document AI models for regulatory drug development submissions.

55 min read

3/4/2026

fda ai framework ai credibility assessment drug development ai model validation regulatory compliance context of use machine learning risk-based validation

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