FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Updates Q&As on Clinical Trials to Evaluate Potential Heart Rhythm Risks

June 20, 2017
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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

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