Drugs

Panel Backs St. Jude PFO Occluder System

FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee has voted 15 to 1 to recommend approval for a St. Jude Medical PMA for its Amplatzer Patent Foramen Ovale (PFO) Occluder System. The device is indicated for percutaneous, transcatheter closure of a PFO to prevent recurrent ischemic stroke in patients who have had a cryptogenic stroke due to a presumed paradoxical embolism. The panel recommended that the labeling include language describing the clinical evaluation of a cryptogenic stroke in patients who might be candidates for the PFO Occluder. It also said the labeling needed a statement regarding the need for adjunctive anti-thrombotic therapy in patients treated with the device. Additionally, the panel recommended that patient selection be carefully considered and defined within the labeling.

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