Drugs

FDA Guide on Neurological Devices Targeting Disease Progression

FDA has released a guidance on “Clinical Considerations for Investigational Device Exemption (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes.” The document is intended to assist sponsors interested in submitting an IDE to conduct clinical trials on devices targeting neurological disease progression and clinically meaningful patient centered outcomes. It focuses on the benefits and risks of medical devices that target either the cause or progression of disorders such as Alzheimer’s disease, Parkinson’s Disease, or Primary Dystonia, rather than their symptoms. “FDA believes that neurological devices intended to slow disease progression and improve clinical outcomes that are meaningful to patients may represent a revolutionary option for patients,” the agency says. The guidance also provides considerations for the research and development of such devices, as well as FDA review considerations to aid in promoting this innovative technology sector.

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