FDA (CDER)
GUIDANCE FINAL
E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential--Questions and Answers (R1): Guidance for Industry
Published: 10/30/2026Detected: 10/30/2026
Summary preview
Clarifies how sponsors should evaluate and document QT/QTc interval prolongation and proarrhythmic risk during both clinical studies and nonclinical assessments.
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#QT/QTc
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#proarrhythmic potential
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#concentration-response
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