E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential–Questions and Answers : Guidance for Industry

 

Issue Date: August 26, 2022
Issued by: Center for Drug Evaluation and Research
Topic(s): ICH-Efficacy, ICH-Safety
Status: Final

E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential–Questions and Answers : Guidance for Industry

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 This guidance finalizes the draft guidance issued in September 2020.

Download the Guidance Document