Drugs

CDER Inspection/Review Leader Doleski Leaves for Sanofi

After 28 years at FDA, CDER Office of Process and Facilities (OPF) acting deputy director David Doleski is leaving next month to accept the position of biologics compliance head at Sanofi Genzyme. At OPF, which is part of the Office of Pharmaceutical Quality (OPQ), Doleski had responsibility for integrating inspection and review functions as part of the Center’s quality assessment. He was also a member of the leadership team that developed the concept of OPQ and was a co-leader of the OPF Transition Team.

Prior to OPF, he worked in CDER’s Office of Manufacturing and Product Quality as a division director for the pre-approval inspection program. Before that, he worked in CBER as a reviewer and inspector for biological products. He began his career In 1990 as a project manager in the Office of Generic Drugs.

Meanwhile, CDER is conducting a national search for a deputy director for operations in the Office of the Center Director. The position will fill a vacancy left by former deputy Richard Moscicki, who joined PhRMA last month as its chief medical officer. CDER director Janet Woodcock says she prefers candidates who have a medical degree and “significant experience leading a large, complex organization or function at the executive level... The CDER deputy director for operations provides leadership related to CDER’s regulatory and scientific programs, including regulatory policies, regulatory staff development, and Center governance. This includes overseeing the development, implementation, execution, management, and direction of major programs that have national and international impact.”

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