Drugs

CDER’s Mullin Promoted to Strategic Programs Head

CDER Office of Strategic Programs director Theresa Mullin has been promoted effective 3/5 to a new position in Center director Janet Woodcock’s immediate office — associate director for strategic initiatives. In her new role, Mullin will oversee “strategic interest” areas that involve external stakeholders. She will continue to lead the Center’s Patient-Focused Drug Development initiative, and work related to the FDA Reauthorization Act and 21^st Century Cures Act implementation. She will also continue to lead CDER’s International Program, which includes reforms to the International Council for Harmonization.

Before joining CDER in 2007, Mullin served as assistant commissioner for planning in the Office of Commissioner. Before that, she was a senior manager with The Lewin Group, specializing in health care consulting, and prior to that, principal scientist at Decision Science Consortium, specializing in decision research and analysis. She received an undergraduate degree in economics from Boston College, and a PhD in public policy analysis from Carnegie-Mellon University.

Office of Strategic Programs deputy director Mary Ann Slack will serve as acting director until a permanent director is hired.

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