Biologics

Prasad Reassumes Chief Medical/Scientific Officer Role

CBER director Vinay Prasad has been reassigned his previous additional duties as FDA’s chief medical and scientific officer, a combination role for commissioner Marty Makary’s closest advisor. In this capacity, “he will serve as a trusted advisor to the FDA commissioner and other senior officials on cross-cutting and emerging medical and scientific issues impacting regulatory science and public health,” an updated bio on FDA’s Web site says.

Last month, Prasad returned to FDA to continue leading CBER at the request of Makary and HHS secretary Robert F. Kennedy Jr. Prasad, who had come under attack from right-wing activist and commentator Laura Loomer, former Sen. Rick Santorum (R-PA), and the Wall Street Journal editorial board (see story), decided to resign in late July to avoid being a distraction for the Trump Administration.

Previously, the agency’s chief scientist and chief medical officer were occupied by two individuals selected by the commissioner. The most recent occupants were Namandjé Bumpus, who served as chief scientist up until she left the agency 12/31/2024, shortly before the new administration came in, and Hilary Marston, who served as the chief medical officer until two months ago when she left the agency in reaction to widespread employee lay-offs.

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