Drugs

Activist Urges Class III for 510(k)-cleared Pneumoliner

Eight days after its 510(k) was cleared, Philadelphia heart surgeon and power morcellation activist Hooman Noorchashm has filed a petition to FDA seeking the immediate reclassification of Advanced Surgical Concepts’ Pneumoliner power morcellation tissue containment device. The petition asks commissioner Robert Califf to require the device to meet premarket approval (PMA) standards and its manufacturer to “perform preclinical and clinical safety trials, subjected to objective cross-disciplinary peer review, to specifically demonstrate oncological safety.”

The petition also asks Califf to “consider whether a clinical trial to demonstrate oncological safety of the Pneumoliner device is even ethically possible (that is, can subject patients with suspected uterine cancer be power morcellated using the Pneumoliner device to determine if their cancers spread?), and to also “involve the FDA’s Office of Hematology and Oncology Products to formally opine and weigh in on whether it is acceptable to retain the Pneumoliner device on the market given its currently unknown oncological risk.”

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