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USFDA Guidance: QTc Information in Prescription Drug & Biological Product Labeling

Recently on 08 August 2023, the United States Food & Drug Administration's Oncology Center of Excellence,

Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research released a draft guidance on “QTc Information in Human Prescription Drug and Biological Product Labeling”.

QTc interval prolongation refers to an electrocardiogram (ECG) measurement that reflects the time it takes for the heart's ventricles to contract and then recover.


A prolonged QTc interval indicates that the time it takes for the heart's electrical system to reset and prepare for the next contraction is longer than normal. This can have important clinical implications, as QTc prolongation is associated with an increased risk of a specific type of potentially life-threatening arrhythmia called Torsades de Pointes.


QTc interval prolongation can be caused by a variety of factors, including certain medications (such as some antiarrhythmic drugs, antipsychotics, and certain antibiotics), electrolyte imbalances (especially low levels of potassium, calcium, or magnesium), genetic factors (such as Long QT syndrome), and certain medical conditions.


The QT corrected for heart rate (QTc) assessment in early clinical development may inform the intensity 59 and continuation of ECG monitoring in late-phase clinical trials. FDA/ICH recommends that sponsors conduct a single clinical trial, named the “thorough QT/QTc study” (TQT study), to assess the effect of a drug on the QTc interval.


The purpose of this guidance is to assist applicants in incorporating information regarding QTc interval prolongation into the labeling of non-antiarrhythmic prescription drugs and biological products for human consumption.


This guidance provides recommendations to assist in ensuring that clinically relevant information on QTc interval prolongation is included in and distributed appropriately across sections of labeling, in compliance with regulatory requirements for human prescription drug content and format.


Click this LINK to know more about Recommended Statements to Describe the Effects of a Drug on the QTc Interval Under the Cardiac Electrophysiology Heading.


Also, check out this recent guidance about "Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products" which describe FDA requirements and provide recommendations for obtaining safety and effectiveness information on drug and biological products, when appropriate, in the postmarketing setting in historically under-represented patient populations in clinical trials.


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