![From QSR to QMSR: Meeting FDA’s New Requirements From QSR to QMSR: Meeting FDA’s New Requirements](https://www.fdanews.com/ext/resources/Book-Covers-NEW/From-QSR-to-QMSR-500.png?height=200&t=1714569011&width=200)
Home » FDA Updates Q&As on Clinical Trials to Evaluate Potential Heart Rhythm Risks
FDA Updates Q&As on Clinical Trials to Evaluate Potential Heart Rhythm Risks
![](https://www.fdanews.com/ext/resources/test/Device_Images5/StethoscopeonTablet.gif?t=1474668613&width=430)
June 19, 2017
The FDA published a set of revisions to an ICH supplement, answering industry questions on the evaluation of certain drugs’ potential to produce abnormal heart rhythms.
The question-and-answer document — stemming from the ICH’s E14 guideline on clinically measuring QT prolongation, first adopted by the FDA in 2005 — includes updates on new technologies, late-stage monitoring and clinical study design for special cases, as well as combination products and large, targeted proteins, including monoclonal antibodies.
Additionally, concentration-response analyses can serve as an alternative to other tests as the primary basis for decisions to classify the risks of a drug, the document says. The revision also includes answers on measuring baseline QTc between men and women, based on differences in prolonged drug exposure. — Conor Hale
Upcoming Events
-
21Oct