Devices

CDRH ODE Director Sheets Resigns

On board for less than a year, CDRH Office of Device Evaluation director John Sheets has left the agency to “pursue other opportunities,” an FDA spokeswoman tells FDA Webview. Center chief scientist Willaim Maisel has assumed acting ODE director duties until a replacement is found. Sheets replaced former director Christy Foreman, who stepped down in 2014 to accept a new position at FDA’s Center for Tobacco Products.

Before coming to FDA, Sheets served as Anika Therapeutics chief scientific officer. Prior to joining Anika in 2013, Sheets was employed at Boston Scientific, where he was senior vice president of corporate research. At Boston Scientific, he was responsible for revitalizing product development by establishing new global processes, creating worldwide technology strategies, and establishing new product sourcing and development networks with a focus on emerging markets.

Prior to his work at Boston Scientific, Sheets was corporate vice president of research and development and chief technology officer for Bausch and Lomb. He also previously served as president of Hoya Surgical Optics and worked for Ethicon (Johnson & Johnson), Alcon Laboratories and Iolab Corporation (Johnson & Johnson) in California. Sheets holds an undergraduate degree and PhD from the University of Florida, Gainesville.

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