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.
Research program
A public research program for tissue-chip translation
NIH / NCATS · Source date not stated
What the source reports
NCATS describes tissue chips built with human cells to model aspects of organ structure and function and investigate potential drug effects.
Why it belongs here
An accessible introduction to what these models are intended to do and why their development matters.
WHAT THIS DOES NOT ESTABLISH
A program’s aims are not proof of universal predictive accuracy. Human-cell models still have important biological limits.
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.
Draft guidance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FDA’s March 2026 draft guidance sets out general scientific considerations for validating New Approach Methodologies in drug development and regulatory submissions.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.