Drugs

Beta Bionics Gets Warning on iLet Bionic Pancreas

FDA has issued Beta Bionics a Warning Letter, citing wide-ranging quality system, complaint handling, reporting, and recall-related violations tied to the company’s iLet Bionic Pancreas System. The 1/28 letter follows a 6/25 inspection of the company’s Irvine, CA facility, concluding that the company’s iLet Dosing Decision Software and iLet ACE Pump — components of the automated insulin-delivery system — are adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act due to systemic regulatory failures.

The letter cited the company’s failure to establish and maintain adequate corrective and preventive action (CAPA) procedures. Investigators found the company did not properly analyze complaint data or implement CAPAs for serious device malfunctions. It also failed to adequately validate device design and incorporate post-market risk data. Other findings include:

Failure to maintain adequate complaint handling procedures
Failure to control nonconforming
Failure to report serious injury events within 30 days
Failure to report device malfunctions likely to cause serious injury if recurring
Inadequate written medical device reporting procedures

Failure to submit required reports of device correction or removal.

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