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

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled "QTc Information in Human Prescription Drug and Biological Product Labeling." 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. The guidance provides recommendations on how and where to appropriately include the clinically relevant information on QTc interval prolongation in the labeling, in accordance with regulatory requirements for the content and format of human prescription drug labeling. This guidance finalizes the draft guidance of the same title issued on August 8, 2023.

Abstract as published in the Federal Register.

The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.