Federal Register Notice: FDA is making available a guidance entitled S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals prepared under the auspices of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. The guidance describes a nonclinical testing strategy for assessing a test substance’s potential to delay ventricular repolarization and includes information on nonclinical assays and an integrated risk assessment. The guidance is intended to facilitate the nonclinical assessment of the effects of pharmaceuticals on ventricular repolarization and proarrhythmic risk. To download this guidance, click here. To view this notice, click here.