Drugs

FDA Regulated Recalls ‘Surge’: Sedgwick Index

The Sedgwick Recall Index for the third quarter of 2021 says both medical device and pharmaceutical recalls “surged.” The index says medical device recalls rose 35.8% from 173 in the previous quarter to 235. And drug recalls surged by 45.8% from 59 last quarter to 86.

Software issues remained the top cause for Q3 medical device recalls, accounting for 41 events (17.4%). Sedgwick says the number of affected units surged 136% over Q2 to 372 million, dwarfing the average quarterly figure of 68 million for the past 10 years.

Mislabeling issues were the second most common reason for recalls (36 events), followed by parts issues (34), quality concerns (29), and safety concerns (29).

FDA labeled 20 of the recalls (8.5%) as Class 1, the index shows. They affected 76.4% of the units recalled in the third quarter.

Sedgwick reports the cGMP deviations were the leading cause of drug recalls (20.9%) and affected units (83.3%). Failed specifications were the second leading cause of recalls, in terms of both events and units, while security issues were third.

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