Regulatory development
Model-informed development has a final ICH framework
Jun 1, 2026 · Added Oct 7, 2026
The development
FDA issued its final ICH M15 guidance in June 2026.
Our reading
A useful reference for teams combining experiments and quantitative models.
The interpretation above is editorial analysis, not a claim made by the source.
US Food and Drug Administration / ICHFinal guidance is nonbinding. MIDD is broader than AI, and a model is not automatically acceptable for every use.
Read the evidence note