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# E14 Guidance Clarification
- URL: https://www.fdaweb.com/e14-guidance-clarification/
- Published: 2017-06-14T12:00:00.000Z
- Updated: 2026-09-14T22:29:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138927

FDA has issued a guidance, *E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs—Questions and Answers (R3)*, to facilitate implementing the International Conference on Harmonization (ICH) 2005 E14 guidance. The [document](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073161.pdf?ref=fdaweb.com) says the questions and answers arise from experiences implementing the guidance in the ICH regions. It revises an 11/2008 question and answer guidance on the same E14 guidance by **(1)** adding questions on concentration-response relationships, combination products, large targeted proteins and monoclonal antibodies, and special cases, and **(2)** harmonizing guidance on how concentration response modeling could be used for regulatory decision-making.