Devices

Groups Question FDA Weight Loss Paper

The Obesity Action Coalition and American Society for Metabolic and Bariatric Surgery say an FDA discussion paper on benefit/risk approaches for weight loss medical devices may not recognize that treating the chronic disease of obesity requires a full continuum of care. The groups’ comment letter says that discussion paper use of language quantifying weight loss treatment as short-term or long-term when applied to devices might not reflect real-world care. The groups also say the agency should consider using a staging system to differentiate care for those who are well versus those who are sick.

In their letter, the Association for Bariatric Endoscopy, the American College of Gastroenterology, the American Gastroenterological Association, and the American Society for Gastrointestinal Endoscopy say a statement in the discussion paper could be interpreted to mean that FDA will require sponsors to perform randomized controlled trials with a sham control arm when this is possible. “Comparing open-label and sham-controlled studies with the same categorization scheme is problematic,” the groups say. They recommend that the proposed benefit categorization should only be used if all future studies are open-label.

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