Devices

Warning Letter Sent to Zimmer Biomet Subsidiary

FDA 8/24 sent a Warning Letter to a Zimmer Biomet subsidiary’s manufacturing facility in Warsaw, IN over GMP issues documented in an April inspection. “We have provided written responses to the FDA detailing corrective actions underway to address the FDA’s observations and have provided, and will continue to provide, regular updates to the FDA regarding our quality remediation plan at the Warsaw North Campus,” the company says in a financial filing. “While the Warning Letter acknowledges our quality remediation plan and actions we’ve already taken to address the FDA’s inspectional observations, it notes violations that require additional action or explanation. In the Warning Letter, the FDA proposes a regulatory meeting with us to discuss the proposed corrections.”

Zimmer says the Warning Letter does not restrict production or shipment of products from the Warsaw North Campus facility or require the withdrawal of any product from the marketplace. “Nor does it restrict our ability to seek FDA 510(k) clearance of products,” it says. “Additionally, premarket approval applications for Class 3 devices to which the Quality System regulation violations are reasonably related will not be approved until the violations have been corrected. We presently have no such applications before the FDA.”

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