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GUIDANCE DOCUMENT

E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs October 2005

Final
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This guidance provides recommendations to sponsors concerning the design, conduct, analysis, and
interpretation of clinical studies to assess the potential of a drug to delay cardiac
repolarization. This assessment should include testing the effects of new agents on the QT/QTc
interval as well as the collection of cardiovascular adverse events. The investigational approach
used for a particular drug should be individualized, depending on the pharmacodynamic,
pharmacokinetic, and safety characteristics of the product, as well as on its proposed clinical
use.
 


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Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.