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GUIDANCE DOCUMENT

E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential--Questions and Answers Guidance for Industry August 2022

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2020-D-1791
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

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 This guidance finalizes the draft guidance issued in September 2020.

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All written comments should be identified with this document's docket number: FDA-2020-D-1791.

 
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