FDA Addresses Gender Differences in ICH QT Guidance Revision

The FDA has revised and clarified a final ICH question-and-answer guidance on the evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs. The newest version addresses issues related to gender differences, incorporation of new technologies, late-stage monitoring and heart rate correction. Drugmakers are “encouraged” but not required to include both men and women in thorough QT studies, the updated ICH E14 guidance states.
Washington Drug Letter