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.
Draft guidance
A validation framework for human-relevant methods
US Food and Drug Administration · Mar 2026
What the source reports
FDA’s March 2026 draft guidance sets out general scientific considerations for validating New Approach Methodologies in drug development and regulatory submissions.
Why it belongs here
The useful question is not whether a model is new, but whether it is reliable for the decision it will support.
WHAT THIS DOES NOT ESTABLISH
Draft, nonbinding guidance, not final guidance or blanket acceptance of any particular NAM.
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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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.
Model performance study
Putting a human Liver-Chip to a predictive test
Ewart and colleagues evaluated a human Liver-Chip for predictive toxicology using a defined set of compounds and an accompanying economic analysis.