Drugs

Low Number of Drug Recalls in Third Quarter: Stericycle

The Stericycle Expert Solutions First Quarter recall index says drug recalls decreased 6.5% to 72, the second-lowest number in the past 12 quarters. However, recalled units stayed high at just over 22 million. “The average number of recalls per quarter so far in 2019 is trending to be the lowest since 2016,” the report says.

CGMP deviation was the top reason for drug recalls, accounting for 25% of all recalls and 93.1% of all recalled units. The average size of a recall was 309,944 units, just 7% lower than in the second quarter. Some 54 companies announced recalls in the third quarter, the lowest number since the third quarter of 2016.

Medical device recalls increased another 21.5% to 243 in the quarter, Stericycle reports. Recalled units increased 1010.8% to 219.2 million, the greatest number of units affected in a quarter since at least 2005. Stericycle says this anomaly was due largely to one recall that accounted for 83% of all recalled units. At 85.3%, quality issues were the top recall cause based on units for the third consecutive quarter. Some 65.8% of the recalls were for products distributed nationwide.

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

Read more

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