Biologics

Prasad Puts Together CBER Leadership Team

CBER director Vinay Prasad has made recent leadership changes at the Center, appointing several new acting deputy directors and reassigning key staff within the Center. Katherine Szarama has moved from HHS’ Advanced Research Projects Agency for Health to be acting CBER deputy director, according to a MedPage Today report. She previously held roles at the Centers for Medicare & Medicaid Services, and at CBER she will focus on policy and governmental relations while contributing more broadly across the Center.

Prasad also named Sonday Kelly as another acting deputy director. Described by Prasad as “a wealth of regulatory information, and a true unsung hero of CBER,” Kelly will provide guidance on administrative and regulatory topics, according to the report.

Brittany Goldberg is moving from Center deputy director to chief medical officer, the report says. She has been at the agency since 2012, and now will shift her focus from administrative responsibilities to medical and scientific issues central to CBER’s work.

Other promotions include Scott Steele, who will head pandemic preparedness within the Office of the Chief Medical Officer; Sundeep Agrawal, who will serve as branch chief of oncology; and John Scott, along with Stephen Chang, who will serve as acting deputy directors of the Office of Biostatistics and Pharmacovigilance .

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