Drugs

FDA Adds New Chief Operating Officer

FDA has appointed former consultant Barclay Butler as deputy commissioner for operations and chief operating officer. In this capacity, Butler has “leadership authority over the management of business programs and operations across the FDA enterprise level, including human resources and facilities,” according to his just-posted bio.

Before joining FDA, Butler ran Barclay Consulting Services, and before that he spent 10 years with the Defense Health Agency, most recently as assistant director for support. Earlier in his career, he was chief information officer for several organizations, including the Office of the Army Surgeon General, the U.S. Army Medical Research and Materiel Command, Walter Reed Army Medical Center, 18th Medical Command, and 44th Medical Brigade at the 18th Airborne Corps.

Butler has his PhD from the University of Michigan and his undergraduate degree in biology from Marquette University. He also has a master’s degree in bioengineering, and a master’s in electrical sciences, both from the University of Michigan.

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