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

On 26 August 2022 the FDA published final Q&A guidance on ICH E14 and S7B.

This question-and-answer (Q&A) document is intended to clarify key issues to facilitate implementing the ICH guidance 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).

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