Interdisciplinary Team Maps A New Course in Thorough QT Studies
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
In October 2007, FDA finalized an interim Manual of Policies and Procedures for an interdisciplinary review team for the review of Thorough QT protocols and studies. As described in the International Conference on Harmonization E14 guidance for industry, most new drugs should be evaluated for effects on cardiac repolarization, indicated by the QT interval. Results of the studies, the MaPP says, may affect regulatory decisions and/or the need for a risk management program.
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