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Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential--Questions and Answers Draft Guidance for Industry September 2020
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- FDA-2020-D-1791
- Issued by:
-
Guidance Issuing OfficeCenter 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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