Devices

FDA Denies DuraSeal Spinal Sealant Petition

FDA has denied a petition filed in 2013 by Thomas Law Company on behalf of tort plaintiff Marteen Moore, who claimed injury caused by DuraSeal Spinal Sealant. The agency response says the device was approved via the PMA process and is indicated for use as an adjunct to sutured dural repair during spinal surgery to provide watertight closure.

The petition asked that FDA:

enforce post-approval conditions of the PMA by ordering the sponsor to complete enrollment in its post-approval study of infection rates (denied as moot because the final study report was submitted in 2016);
investigate risks disclosed in the labeling that were not discussed in the PMA and require revisions to the labeling and package inserts (denied as not needed);
investigation of an allegation of false advertising (denied);
investigate the sponsor’s compliance with its duties to report serious adverse effects to FDA (denied);
disclose the identities and contact information of adverse event reporters (denied); and
grant a hearing concerning “denied disclosure of the sponsor’s complaint files and serious adverse event reports for the product by both the sponsor and the agency” (denied).

The petition also sought temporary suspension of the PMA for violations of the Federal Food, Drug, and Cosmetic Act, FDA says, and that request also was denied.

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