Business · 30/09/2020
FDA Releases Draft Guidance on Evaluating QT/QTc Interval Prolongation and Proarrhythmic Potential
The FDA has published a draft guidance for industry on evaluating the QT/QTc interval prolongation and proarrhythmic potential of pharmaceuticals, developed in collaboration with the International Council for Harmonisation, to provide recommendations on integrated risk assessment combining nonclinical and clinical data.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →