Drugs

‘Major Disruption’ Clinical Trial Guidance

FDA has published a guidance, Considerations for the Conduct of Clinical Trials of Medical Procedures During Major Disruptions Due to Disasters and Public Health Emergencies, to assist sponsors, institutional review boards, and clinical investigators in assuring the safety of trial participants, maintaining compliance with good clinical practice, and minimizing risks to trial integrity during disasters and public health emergencies (PHEs) that may lead to major disruption of clinical trial conduct and operations. The document says disasters and public health emergencies can include, but are not limited to, hurricanes, earthquakes, military conflicts, infectious disease outbreaks, or bioterrorist attacks.

FDA says it is aware that not all trials can be initiated or continued during disasters and PHEs, and for some trials, there may be no alternative to stopping the trial earlier than planned to safeguard participants’ and trial staff’s safety. “The determination of whether to continue a trial should be based first and foremost on ensuring that participants will continue to be able to participate safely,” the guidance says. “The determination should also consider whether the key objectives of the trial can still be met, with appropriate trial modifications implemented.”

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

Read more

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