> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# ICH Revised Guide on Assessing Drug-Induced Cardiac Arrhythmia Risks
- URL: https://www.fdaweb.com/ich-revised-guide-on-assessing-drug-induced-cardiac-arrhythmia-risks/
- Published: 2026-10-30T14:53:01.000Z
- Updated: 2026-10-30T14:53:01.000Z
- Author: David McFarland
- Tags: Drugs

FDA has posted an International Council for Harmonization revised final guidance to clarify how drug developers should evaluate the potential for investigational drugs to prolong the QT/QTc interval and cause potentially serious cardiac arrhythmias, including circumstances in which traditional clinical cardiac safety studies may not be feasible. The guidance, [ICH E14/S7B questions-and-answers guidance](https://www.fda.gov/media/161198/download?ref=fdaweb.com), contains revisions endorsed in August by international regulators.

According to the document's revision history, the changes update three ICH E14 questions addressing concentration-response modeling of QTc data (Q&A 5.1), alternative approaches when conventional thorough QT studies are impractical (Q&A 6.1), and cardiac safety evaluation of certain therapeutic modalities, including monoclonal antibodies and large targeted proteins (Q&A 6.3).

The document describes how integrated assessments combining clinical electrocardiographic findings with nonclinical evidence can inform cardiac safety evaluations, particularly when conventional thorough QT studies cannot be conducted.

It also revises or introduces questions in Sections 1 and 3 of ICH S7B, addressing integrated nonclinical risk assessment and best practices for in vivo QT studies.

The recommendations address the sensitivity of nonclinical assays, drug exposure levels and the use of pharmacokinetic and pharmacodynamic analyses to support interpretation of cardiac safety findings.

The guidance is intended to facilitate implementation of the longstanding ICH E14 and S7B recommendations governing clinical and nonclinical assessment of drug-related cardiac repolarization risks.