Devices

FDA Denies Vagus Nerve Stimulation Petition

FDA has denied a 9/6/06 Public Citizen Health Research Group petition asking it to revoke the Cyberonics PMA approval for its Vagus Nerve Stimulation device for managing treatment-resistant depression (TRD). The petition claimed that the device was “ineffective” for TRD and has not demonstrated a reasonable assurance that it is safe and effective for TRD.

The denial letter says FDA determined in 2003 that the company had provided reasonable assurance of safety and effectiveness of the device for managing TRD. FDA says it disagrees with the petition’s contentions because (1) Public Citizen presented no evidence demonstrating that the VNS device is ineffective for managing TRD or any new evidence demonstrating a lack of a showing of reasonable assurance of safety and effectiveness for the device, and (2) the results of two post-approval studies required by the approval constitute additional valid scientific evidence supporting a reasonable assurance of safety and effectiveness of the device for managing TRD and the agency’s decision to approve it for that use.

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