E14 and S7B clinical and nonclinical evaluation of QT/QTc interval prolongation and proarrhythmic potential: questions and answers

E14 and S7B clinical and nonclinical evaluation of QT/QTc interval prolongation and proarrhythmic potential: questions and answers

Collection:
Health Policy and Services Research
Contributor(s):
United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Drug Evaluation and Research (U.S.), issuing body.
Center for Biologics Evaluation and Research (U.S.), issuing body.
Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, August 2022
Language(s):
English
Format:
Text
Subject(s):
Arrhythmias, Cardiac
Clinical Trials as Topic
Electrocardiography
Government Regulation
United States
Genre(s):
Guideline
Technical Report
Abstract:
This question-and-answer (Q&A) document is intended to clarify key issues to facilitate implementing the ICH guidances for industry E14 Clinical Evaluation of the QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs (October 2005) and S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals (October 2005).2 This guidance revises ICH E14 Q&As Q12 (5.1) and Q13 (6.1), and adds new ICH S7B Q&As Q17 (1.1) to Q30 (4.2). This guidance finalizes the draft guidance issued in September 2020. The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law. FDA guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  The use of the word should in Agency guidance means that something is suggested or recommended, but not required.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (28 pages))
NLM Unique ID:
9918486675906676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918486675906676