Draft guidance
A validation framework for human-relevant methods
FDA’s March 2026 draft guidance sets out general scientific considerations for validating New Approach Methodologies in drug development and regulatory submissions.
Draft guidance
AI credibility depends on the question being asked
US Food and Drug Administration · Jan 2025
What the source reports
FDA’s January 2025 draft describes a risk-based approach to evaluating AI models used to support regulatory decisions about drugs and biological products.
Why it belongs here
AI can suggest directions as well as accelerate work. Its evidence must still be credible for the intended use.
WHAT THIS DOES NOT ESTABLISH
Draft, nonbinding recommendations. A technically impressive prediction is not equivalent to demonstrated clinical utility.
Before you use it
Read the original source, check its population or model and intended use, and review uncertainty, disclosures and any subsequent updates. This note is a guide to reading, not a substitute for the paper or guidance.
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Final guidance
How model-informed evidence should support a decision
ICH M15 addresses planning, evaluation and documentation of model-informed drug-development evidence. FDA’s final guidance is dated June 2026.
Regulatory explainer
A biomarker needs a clearly defined job
FDA distinguishes biomarker categories and explains qualification within a stated context of use. A biomarker can be a molecular, tissue, imaging or physiological measurement.