Drugs

QTc Information Labeling Guidance

FDA has published a guidance, QTc Information in Human Prescription Drug and Biological Product Labeling, to assist applicants in incorporating heart rate-corrected (QTc) interval of prolongation-related information in the labeling of non-antiarrhythmic human prescription drug and biological products. The document provides recommendations to help ensure that clinically relevant information on QTc interval prolongation is included in and distributed appropriately across sections of labeling, according to regulatory requirements for the content and format of human prescription drug labeling.

FDA says the guidance contains QTc interval prolongation-related information in the labeling of a fictitious drug. It does not address methodological considerations for evaluating or interpreting QTc interval prolongation data.

Included in the guidance are an Introduction, Background, QTc Interval Prolongation Information in the Clinical Pharmacology Section, QTc Interval Prolongation Information in the Drug Interactions Section, QTc Interval Prolongation Information in the Warnings and Precautions Section, QTc Interval Prolongation Information in Other Sections of Labeling, QTc Interval Prolongation Information in FDA-Approved Patient Labeling, and Submitting Labeling with QTc Interval Prolongation Information.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome