Business · 29/08/2022
FDA Releases Final Guidance on Evaluating QT/QTc Interval Prolongation and Proarrhythmic Potential
The FDA has released a final 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 a harmonized approach to integrating nonclinical and clinical data for proarrhythmic risk assessment.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →