Draft guidance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FDA’s March 2026 draft guidance sets out general scientific considerations for validating New Approach Methodologies in drug development and regulatory submissions.
Test guideline
Skin science offers a practical example of fit-for-purpose NAMs
OECD · Jun 25, 2025
What the source reports
OECD Test Guideline 439 describes reconstructed human epidermis methods for identifying skin irritation hazards in a defined testing context.
Why it belongs here
Human-relevant evidence already has practical applications in skin and cosmetic safety assessment.
WHAT THIS DOES NOT ESTABLISH
This is an irritation-hazard method, not evidence of cosmetic efficacy, skin rejuvenation or longer healthy life.
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.