The new ICH M12 guideline on drug interaction studies provides a harmonized approach expected to be implemented by the major regulatory authorities such as the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and presumably replace their respective existing guidance.
Explore the differences between the 2020 FDA Guidance and the 2024 ICH M12 Guideline with our handy reference document.