The FDA issued a draft guidance to help applicants incorporate QTc interval prolongation-related information into the labeling of non-antiarrhythmic human prescription drug and biological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.
Comments should be submitted by October 7, 2023, to ensure the FDA reviews them prior to work on the final version of the guidance.
QTc Information in Human Prescription Drug and Biological Product Labeling