Devices

Device Compliance Head Newman Leaves FDA

CDRH Office of Compliance director Robin Newman has left the agency to pursue an undisclosed opportunity. She joined the Center 2/2016 after leaving Siemens Healthcare Diagnostics as its quality management vice president. Newman has over 20 years of senior level clinical/regulatory and compliance management in new product research and development. She’s served as a senior level consultant for regulatory strategy, clinical trial design and execution, standards and SOP development, quality system management and compliance, clinical and medical writing, and management of data safety monitoring boards and clinical event adjudication committees.

“As CDRH looks toward transitioning to a Total Product Life Cycle (TPLC) organization, Dr. William Maisel assumed the role of director of CDRH’s Office of Compliance (effective Oct. 23, 2017) in addition to his role as director of CDRH’s Office of Device Evaluation,” an FDA spokeswoman told FDA Webview 11/3. “Once the TPLC organization is implemented, Dr. Maisel will be the director of the new TPLC Office.”

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