QTc Info in Human Prescription Drug and Biological Product Label

Docket Number: FDA-2023-D-2439 Issued by:

Guidance Issuing Office

Oncology Center of Excellence

Center for Drug Evaluation and Research

Center for Biologics Evaluation and Research

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.

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Dockets Management
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All written comments should be identified with this document’s docket number: FDA-2023-D-2439.

• Content current as of:

  12/02/2025

• Regulated Product(s)

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