Drugs

Corrigan-Curay on Detail on CDER Director’s Office

CDER Office of Medical Policy (OMP) director Jacqueline Corrigan-Curay has accepted a detail to the Office of the Center Director as deputy director for operations, effective 2/14. While acting in this position, Corrigan-Curay will continue in her role as OMP director.

Corrigan-Curay’s temporary move is due to workload increases related to the Covid-19 response, according to CDER acting director Patrizia Cavazzoni. “Jacqueline will work on certain high-priority Center or agency-level programs or initiatives, while also continuing to lead the GDUFA 3 reauthorization negotiations,” she says. “As OMP director since 2016, Jacqueline has led staff in implementing medical policy programs and strategic initiatives for real-world evidence, drug labeling, prescription drug promotion, clinical trial oversight, and innovative trial design. Jacqueline also serves as a member of CDER’s Executive Committee, where she helps identify strategic priorities for the center and gives input on budget, hiring, technology, and investments.”

Before joining CDER, Corrigan-Curay served at NIH’s National Heart, Lung, and Blood Institute (NHLBI) on an initiative to optimize NHLBI’s clinical trials. She also served as the director of the Office of Biotechnology Activities, in the Office of NIH Director, focusing on optimizing the responsible conduct of clinical trials and laboratory research.

Corrigan-Curay has a law degree from Harvard Law School, and a medical degree from University of Maryland School of Medicine.

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