Drugs

FDA Posts 483 of iRhythm’s CA Facility

A just-posted, four-item Form FDA-483 provides more detail on medical device reporting (MDR) and other violations cited in a 2022 inspection of iRhythm’s Cypress, CA manufacturing facility that led to a recent Warning Letter on its ZIO AT arrhythmia monitoring system. The inspection form cited the firm for 28 complaints about patient episodes that should have been reported to their physicians but were blocked due to the device reaching its maximum threshold for report transmission.

FDA’s inspection also reviewed 39 patient tickets where physician-reportable episodes occurred, but report transmission did not process because the patient registration was incomplete. During the inspection, the tickets were still opened and the records did not show follow up on the patient status to determine the impact of any delayed physician notifications, according to the 483. Additionally, the firm was cited for failing to submit an MDR to FDA no later than 30 calendar days after the day that iRhythm received or otherwise became aware of information that reasonably suggested that its device a may have caused or contributed to a death or serious injury.

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