QTc Information in Human Prescription Drug and Biological Product Labeling: Guidance for Industry

Issue Date: December 3, 2025
Issued by: Oncology Center of Excellence
Topic(s): Labeling
Status: Final

QTc Information in Human Prescription Drug and Biological Product Labeling: Guidance for Industry

This guidance is intended to assist applicants with incorporating heart rate-corrected QT (QTc) interval prolongation-related information into the labeling of non-antiarrhythmic human prescription drug and biological products. This guidance provides recommendations to help ensure that clinically relevant information on QTc interval prolongation is included in and distributed appropriately across sections of labeling, in accordance with regulatory requirements for the content and format of human prescription drug labeling.

Download the Guidance Document

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