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FDA posts ICH S7B guidance on nonclinical assessment of delayed ventricular repolarisation

🇺🇸 FDA CBER · Fri 30 Oct 2026

The guidance, issued through CBER and CDER, outlines a nonclinical testing strategy for QT-related risk, including assays and integrated risk assessment, and may be revised as data accumulate.

The US Food and Drug Administration has published the ICH S7B guidance on the nonclinical evaluation of the potential of human pharmaceuticals to delay ventricular repolarisation, which is reflected in QT interval prolongation. The page is listed under docket FDA-2004-D-0366 and is marked as current as of 30 October 2026.

The document is issued jointly by the Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research. It covers both biologics and drugs and sits under the agency's ICH-Safety topic.

According to the FDA, the guidance describes a nonclinical testing strategy for judging whether a test substance can delay ventricular repolarisation. It includes information on nonclinical assays and on integrated risk assessments.

The agency notes that the assessment of drug effects on ventricular repolarisation and proarrhythmic risk remains under active investigation. It says additional nonclinical and clinical data will be evaluated as they accumulate, and the guidance might be revised as a result. The source does not describe any specific changes in this posting.

The FDA also points readers to a related resource, the E14 and S7B Questions and Answers (R1) document on clinical and nonclinical evaluation of QT/QTc interval prolongation and proarrhythmic potential. Comments on the guidance can be submitted at any time, online or by post to the FDA's Dockets Management office in Rockville, Maryland, quoting the docket number.

What it means for your team

  • Nonclinical and safety pharmacology teams should check their QT-risk testing strategies against the current S7B text, including its assay and integrated risk assessment content.
  • The FDA flags that the guidance might be revised as new data emerge, so teams should monitor the docket for updates.
  • Teams should read S7B alongside the E14 and S7B Q&A (R1) document that the FDA lists as an additional resource.
  • Comments are accepted at any time under docket FDA-2004-D-0366.

Official source: FDA CBER ↗

Article written by VigiEye from the official source (FDA CBER). AI-assisted; check the source before acting.

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