Foundational analysis
Why better tools did not automatically mean better R&D
Scannell and colleagues described a historical decline in new drug approvals per inflation-adjusted R&D dollar, despite improvements in many discovery tools.
Final guidance
How model-informed evidence should support a decision
US Food and Drug Administration / ICH · Jun 2026
What the source reports
ICH M15 addresses planning, evaluation and documentation of model-informed drug-development evidence. FDA’s final guidance is dated June 2026.
Why it belongs here
It makes the intended decision, model credibility and documentation central to the use of quantitative evidence.
WHAT THIS DOES NOT ESTABLISH
Final guidance is nonbinding. MIDD is broader than AI, and a model is not automatically acceptable for every use.
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Draft guidance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FDA’s March 2026 draft guidance sets out general scientific considerations for validating New Approach Methodologies in drug development and regulatory submissions.
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.