Devices

IVD Director Timothy Stenzel Retires

CDRH Office of In Vitro Diagnostics (OIVD) director Timothy Stenzel has retired and a national search is underway to fill the vacant position. Stenzel joined FDA 7/2018 after long careers in both academics and industry, which included oversight of test development for both Clinical Laboratory Improvement Amendment labs and in vitro diagnostics manufacturers. He received an MD and PhD in microbiology and immunology from Duke University. Prior to joining the agency, Stenzel served as chief operating officer at Invivoscribe (San Diego, CA) from 2014 to 2018, focusing on companion diagnostics and next generation sequencing in oncology.

Until a new director is appointed, CDRH Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices director Courtney Lias will serve as acting director over IVDs, a Center spokeswoman told FDA Webview. She has been at the agency for over 20 years and previously served as OIVD deputy director for patient safety and product quality.

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