Devices

FDA Taps Siemens VP for Device Compliance Director

Former Siemens Healthcare Diagnostics quality management vice president Robin Newman has been selected as CDRH Office of Compliance director, effective 2/22. Newman replaces Steve Silverman, who left the agency a year ago to join McKinsey & Company as a senior expert, medical product quality, compliance, and remediation.

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.

At Siemens, she managed a multidisciplinary quality management team, overseeing GMP and ISO compliance, GCP compliance and clinical trial development, quality engineering and risk management, auditing and compliance, personnel development, and outside-U.S. product registrations and regulatory support. She was a member of the Siemens global regulatory affairs team for new regulations/standards, reimbursement and government affairs, and a primary representative for AdvaMedDx and the Diagnostic Tests Working Group.

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