Drugs

OGD Director Choe Leaving FDA Next Month

After three and a half years at the helm, CDER Office of Generic Drugs (OGD) director Sally Choe is leaving FDA effective 10/8 to “pursue opportunities outside the agency,” according to Center director Patrizia Cavazzoni.

Choe rejoined FDA from a stint in industry in 2016 as CDER Office of Study Integrity and Surveillance (OSIS) deputy director where she was involved with FDA’s Bioresearch Monitoring program — directing inspections of bioequivalence and bioavailability studies and non-clinical laboratories. From 2011 to 2016, she was senior director at Parexel International, overseeing the Asia-Pacific region and Japan offices, as well as managing the global vice president technical consultant group. In this role, she assisted global pharmaceutical companies with developing drug/biologics/biosimilar/device products and their market approvals around the world.

From 2006 to 2011, Choe was leader of the metabolism and endocrinology team in CDER’s Office of Clinical Pharmacology, where she supervised scientists in clinical and pharmacology review and evaluation of regulatory submissions. Before joining FDA back then, she was clinical pharmacology manager at Pfizer and a research investigator at Bristol-Myers Squibb.

While a search is underway for a permanent director, CDER Office of Lifecycle Products director Susan Rosencrance will serve as acting OGD director.

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