FDA Policy/General

Califf Adds 2 Senior Officials to Leadership Team

FDA commissioner Robert Califf has announced that former Johns Hopkins School of Medicine professor Namandjé N. Bumpus has joined the agency as its new chief scientist, and former White House Covid Response Team member Hilary D. Marston has been named chief medical officer.

As chair of Johns Hopkins’ Department of Pharmacology and Molecular Sciences chair, Bumpus led a unit of more than 100 people working on various aspects of drug and diagnostic discovery and development. “Dr. Bumpus has achieved international recognition for her work and research, which spans basic, translational, and clinical efforts, focusing on drug evaluation science and the development of innovative approaches and novel platforms for pharmacological analysis, drug discovery, drug development, toxicology, biomarker development and personalized/precision medicine, including through the application of bioinformatic tools,” Califf said.

The commissioner said that acting chief scientist for the past eight months, Jacqueline A. O’Shaughnessy, will continue to serve in the Office of the Chief Scientist as deputy director.

Before joining the White House Covid-19 Response Team, Marston served as director for Biomedical Preparedness and Response at the National Security Council. Previously, she also worked as policy advisor for pandemic preparedness for the Director of the National Institute of Allergy and Infectious Diseases. She also served in leadership roles for Operation Warp Speed, focused on the development of vaccines and therapeutics.

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