WASHINGTON, Dec. 3 -- Food and Drug Administration has issued a notice called: QTc Information in Human Prescription Drug and Biological Product Labeling; Guidance for Industry; Availability.
The notice was published in the Federal Register on Dec. 3 by Lowell M. Zeta, Acting Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: 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...