FDA Publishes Guidance with Recommendations on Including QTc Information in Drug Labeling

The U.S. Food and Drug Administration (FDA) recently published the guidance for industry, QTc Information in Human Prescription Drug and Biological Product Labeling (December 2025). This guidance provides recommendations to help ensure clinically relevant information on heart rate-corrected QT (QTc) interval prolongation (certain changes in the electrical activity of the heart) is included in the U.S. Prescribing Information of non-antiarrhythmic prescription drugs (prescription drugs that do not treat arrhythmias).