Drugs

Drug Recalls Down, Device Recalls Up: Sedgwick

Drug recall events dropped 14.5% in the first quarter of 2024 below the fourth quarter of 2023, according to the Sedgwick Recall Index for the first quarter. The index shows that failed specifications were the leading cause, affecting 23.2% of the 112 recalls. The total affected units fell 46.4% from 17.3 million to 9.3 million, Sedgwick says.

For medical devices, the index found, recalls increased by 13.8%, from 260 in the fourth quarter of 2023 to 296 in the first quarter of 2024. Quality concerns were the leading cause of medical device recalls in the quarter, affecting 17.2% or 51 events. Despite an increase in the number of recalls, the total affected units dropped 51.2% from 109.3 million in the fourth quarter to 53.4 million in the first quarter.

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