Resource to use
Source date not statedFrom model output to decision-ready evidence
FDA’s M15 resource center brings together templates and examples for assessing model-informed evidence.
SIGNALS
Worth noticing.
Worth questioning.
Selected developments and research worth revisiting. Source dates are explicit; older findings are not presented as breaking news.
Regulatory development
Jun 1, 2026Model-informed development has a final ICH framework
FDA issued its final ICH M15 guidance in June 2026.
Draft guidance
Mar 1, 2026For NAMs, validation is the central question
FDA’s draft NAM guidance outlines general considerations for validation and reporting.
Method in practice
Jun 25, 2025Human-relevant methods are not only a pharma story
OECD TG 439 provides an established, purpose-specific example in skin irritation assessment.
Research to revisit
Aug 8, 2024An aging signature is an instrument, not a verdict
The 2024 proteomic aging study remains a useful entry point into biological risk measurement.