Drugs

FDA Expanding Online Weekly Recall Report

FDA says it believes the public would benefit from having recall information about FDA-regulated products as soon as possible, even if more agency evaluation and classification of a recall remains to be done. Office of Enforcement and Import Operations director Douglas Stearn writes in an FDA Voice blog post the agency is changing its protocol for listing recalls in the weekly online Enforcement Report to include recalls that have not yet been classified.

“Historically,” he writes, “only recalls that have already been classified into one of three categories based on the severity of the hazard have been listed in the report…. However, recall classification can sometimes take weeks, or even months, when FDA needs to conduct a complex evaluation…. Moving forward, FDA will include ‘not-yet-classified’ recalls of human drugs, foods, and veterinary products in the weekly Enforcement Report, even while classification work is still ongoing.”

Posting not-yet-classified recalls will not affect the agency’s protocols for working with companies to ensure that they quickly alert entities in the supply chain as soon as they have identified a problem with their marketed product, Stearn writes. And, he says, FDA will continue to monitor a recalling company’s actions to correct or remove products held by retailers, pharmacies, grocery stories, and hospitals.

The agency also has begun posting early summaries of correction or removal actions involving serious problems with medical devices in the Medical Device Recalls Database, Stearn says. And it has enhanced its Web site’s search capabilities.

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