FDA Issues Final Guidance on Heart Risk Data in Drug Labeling
December 09, 2025
December 09, 2025
WASHINGTON, Dec. 9 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has published a final guidance to help companies incorporate information about heart-related risks into the labeling of prescription drugs and biological products.
The guidance entitled "QTc Information in Human Prescription Drug and Biological Product Labeling" focuses on how to include heart rate-corrected QT (QTc) interval prolongation data for non-antiarrhythmic . . .
The guidance entitled "QTc Information in Human Prescription Drug and Biological Product Labeling" focuses on how to include heart rate-corrected QT (QTc) interval prolongation data for non-antiarrhythmic . . .