FDA Policy/General

Principal Deputy Commissioner Abernethy Leaving FDA

FDA principal deputy commissioner and acting chief information officer Amy Abernethy will be leaving the agency in the next few weeks. “Throughout multiple commissioner transitions and a historic pandemic, Amy’s focus on the FDA’s core technology operations has resulted in a remarkable modernization of the agency’s technology and data practices,” FDA acting commissioner Janet Woodcock said in an email to employees.

“When COVID-19 struck, Amy rapidly assembled flexible teams and projects to understand how novel data and rigorous analysis techniques could be deployed in support of the FDA’s response to the pandemic,” Woodcock said. “Amy’s insight that a diverse group of public health and data experts from multiple sectors could come together to work on pandemic-related analysis projects in a transparent, collaborative setting led to the creation of the Covid-19 Evidence Accelerator, which has emerged as a unique and promising model for advancing the science of public health.”

Abernethy joined FDA two years ago after serving as Flatiron Health chief medical officer. Previously, she served as a professor at Duke University School of Medicine and directed the Center for Learning Health Care in the Duke Clinical Research Institute.

FDA watchers are not surprised by Abernethy’s departure after she was passed over by the Biden Administration in favor of Woodcock to serve as acting commissioner.

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