Devices

FDA Seeks Injunction Against Steiner Biotechnology

On behalf of FDA, the Justice Department has asked the Nevada federal court to issue an injunction to stop Steiner Biotechnology from manufacturing and selling adulterated and misbranded dental products. A department media statement says FDA inspected the Steiner manufacturing facility at least four times from 2018 to 2025, finding repeated violations of current good manufacturing practice and quality system regulations.

“FDA also repeatedly warned the Steiners (company owners Gregory and Roslynn Steiner) that their company was distributing Class 3 medical devices for which they do not have an approved premarket application, a cleared premarket notification submission, or an effective investigational device exemption,” the statement says. “Despite numerous warnings from FDA over the past seven years and the Steiners’ repeated promises, the Steiners continue to violate the Federal Food, Drug, and Cosmetics Act.”

The government says it is seeking an injunction requiring the Steiners to implement sanitation and process improvements and to comply with legal requirements before manufacturing or distributing any additional dental products.

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