Drugs

FDA Issues Data Monitoring Committee Draft Guide

FDA has made available a draft guidance entitled “Use of Data Monitoring Committees in Clinical Trials.” The document provides recommendations to help clinical trial sponsors determine when a data monitoring committee (DMC) would be useful for trial monitoring, and the procedures and practices that should be considered to guide their operation.

“Although all clinical trials have a plan for monitoring data and subject safety, not all trials call for involvement or monitoring by a DMC,” the guidance says. “An important consideration in determining whether to use a DMC in a development program is whether DMC review is practical for the particular clinical trial. Although the practicality of having a DMC for long-term trials is well established, it is not as clear for short-term trials. If the trial is likely to complete enrollment quickly and the follow-up period is short, convening a DMC to review interim data to assess continued exposure of subjects to investigational interventions may be impractical and of little value.”

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