Devices

Stimulation Device Final Rule Delay Sought

FDA has just released a 3/20 petition submitted by the Judge Rotenberg Educational Center, Canton, MA, asking that the agency immediately and indefinitely stay the two effective dates for its final regulation banning electrical stimulation devices used to treat self-injurious or aggressive behavior. The petition, which asked for a decision by 3/27, said the center treats a small percentage of its patients who engage in the most severe and most treatment-resistant self-injurious or aggressive behaviors with an electrical stimulation device known as a graduated electrical decelerator (GED) device as part of a comprehensive, court-ordered, and court-monitored behavioral treatment plan.

“Any efforts taken to prematurely transition JRC’s patients from their current successful, effective, court-ordered treatment with GED devices would, in the opinion of their treating healthcare providers, result in irreparable harm,” the petition states. “So too would a prohibition on GED treatment for JRC patients who, in the opinion of their treating healthcare providers, need such treatment because they have not meaningfully improved with other means of treatment. FDA improperly demands that they must continue with ineffective treatments, without regard to those individuals’ specific treatment histories, or medical conditions and individual needs.”

The petition says that unless the agency committed to a stay of the final regulation by noon on 3/27, the center would seek interim relief from the DC Circuit Court of Appeals.

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