QTc Information in Human Prescription Drug and Biological Product Labeling | FDA

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. Submit Comments Submit Comments Online You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5)) If unable to submit comments online, please mail written comments to: Dockets Management Food and Drug Administration 5630 Fishers Lane, Rm 1061 Rockville, MD 20852 All written comments should be identified with this document's docket number: FDA-2023-D-2439.