Drugs

ICH Guide on Evaluating QT/QTc Interval Prolongation

FDA has released a final guidance entitled “E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential — Questions and Answers.” The International Council for Harmonization (ICH) document is intended to clarify key issues related to implementing earlier guidances on clinical evaluations of QT/QTc interval prolongation.

For example, a question about fully automated technologies becoming available to measure ECG intervals and what would be expected of a sponsor that wished to validate and apply an automated reading method for regulatory submissions is addressed in the guidance. “Efforts to develop more sophisticated and reliable methods for automated ECG readings for both QT interval and T wave morphology assessment are encouraged,” the new guidance says. “There are at present no large-scale studies to validate the use of fully automated reading methods in patients; however, there are examples of thorough QT/QTc studies in healthy volunteers in which automated methods have been used and validated for QT interval measurements against manual methods.”

While is also says that currently there are no clear and widely accepted criteria for validation of new semi-automated or automated methods, “it is expected that each would be validated independently for its ability to detect the QT/QTc prolongation effects of drugs that are near the threshold of regulatory concern. Data supporting the validation of a new method should be submitted and could include descriptive statistics, Bland-Altman plots of agreement, superimposed plots of the baseline- and placebo-adjusted QTc and the RR as a function of time, together with data from any trials that have employed the method.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome