Draft guidance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FDA’s March 2026 draft guidance sets out general scientific considerations for validating New Approach Methodologies in drug development and regulatory submissions.
Tools & templates
A practical toolkit for model-informed development
US Food and Drug Administration · Source date not stated
What the source reports
FDA’s M15 resource center links the guidance, an overview, evidence-assessment templates and worked examples.
Why it belongs here
Useful when the next step is documenting how a model supports an actual development decision.
WHAT THIS DOES NOT ESTABLISH
Use the templates with the guidance and the specific scientific context, not as a checklist that guarantees regulatory acceptance.
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.
Open the original sourceKeep exploring.
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.