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GUIDANCE DOCUMENT

E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential--Questions and Answers Draft Guidance for Industry September 2020

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2020-D-1791
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrythmic Potential—Questions and Answers

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