Drugs

CDER Hires ex-Merck Exec as New Drugs Deputy

FDA has hired former Merck executive Peter Stein to serve as CDER Office of New Drugs (OND) deputy director effective 11/14. As OND deputy, Stein will work to set guidance and policy to ensure an efficient drug development and review process, which includes maintaining effective communications with regulated industry during drug development as it concerns a wide variety of clinical, scientific, and regulatory matters.

Stein comes to FDA with more than 30 years of academic, clinical, and industry experience, with a focus on metabolism and endocrinology product research and development. He previously worked at Merck Research Laboratories, serving as vice president for late stage diabetes and endocrinology development. prior to Merck, he was vice-president, head of metabolism development at Janssen, where he led the Invokana (canagliflozin) development program, and other diabetes and metabolism development efforts. For the past 15 years, he has served as an attending outpatient physician for endocrinology at Robert Wood Johnson University Hospital, and as associate clinical professor for endocrinology at Robert Wood Johnson Medical School.

Stein has a medical degree from University of Pennsylvania and a bachelor’s degree from the University of Rochester.

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