Human observational study
What a proteomic aging clock can tell us
A 204-protein clock, developed using 45,441 UK Biobank participants, was associated with future disease and mortality risk and evaluated in Chinese and Finnish cohorts.
Regulatory explainer
A biomarker needs a clearly defined job
US Food and Drug Administration · Source date not stated
What the source reports
FDA distinguishes biomarker categories and explains qualification within a stated context of use. A biomarker can be a molecular, tissue, imaging or physiological measurement.
Why it belongs here
Specify what the measurement supports: monitoring, prognosis, treatment response, safety or another defined purpose.
WHAT THIS DOES NOT ESTABLISH
Qualification is context-specific. A measured biological change is not itself evidence that a person feels, functions or survives better.
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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Draft guidance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FDA’s March 2026 draft guidance sets out general scientific considerations for validating New Approach Methodologies in drug development and regulatory submissions.
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.