Devices

Zimmer Biomet FDA-483 Response

FDA has just released Zimmer Biomet’s detailed 12/21/16 response to observations in an FDA-483 issued 11/22/16 following an inspection at the company’s Warsaw North Campus in Warsaw, Indiana. “We recognize and take seriously the significance of the observations in the FDA-483, are committed to taking all actions necessary to ensure that our systems are in compliance with FDA requirements, and are steadfast in our determination to ensure that our products are safe and effective,” the letter says. “As described in our attached detailed response, we have taken and are continuing to take actions to address systemic issues.”

The company says it has taken action to address the quality culture at the site and describes the work that was done following the 6/24/15 Zimmer Biomet merger. “Once the merger was completed, the new Zimmer Biomet corporate management team conducted audits, learned of issues through the audits, and promptly initiated corrective actions,” the company says. “Improvements were well underway when FDA started the inspection and will continue with strong support, oversight, and resources.”

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