Drugs

Ibrahim Appointed CDER Deputy Center Director

Sarah Ibrahim has been appointed CDER deputy center director for Regulatory Programs, a role she has been serving in an acting capacity since January. In this role, Ibrahim serves on CDER’s senior leadership team and supports the Center director by providing executive leadership on strategic initiatives that advance CDER’s mission according to her bio on the agency’s Web site.

Ibrahim has earned a Ph.D. in Pharmaceutical Sciences (Biopharmaceutics/Pharmaceutics) from the University of Cincinnati and a B.S. in Pharmacy (Honors) from Cairo University. Prior to joining FDA in 2014, she held roles in the U.S. pharmaceutical industry focused on pharmaceutical development and served on faculty in academia.

Ibrahim has extensive scientific review experience that spans both new drug and generic drug programs, including biopharmaceutics and risk‑based CMC assessments, cross‑disciplinary labeling recommendations, and support for inspections of FDA‑regulated facilities. Her work covers CDER offices responsible for new drugs and for generic drugs, strengthening consistency and science‑based decision‑making across the development lifecycle.

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