Drugs

Woodcock Selects Deputy Director to Lead Office of New Drugs

CDER director Janet Woodcock has announced that Office of New Drugs (OND) deputy director Peter Stein has been selected as permanent director of the Office. Stein replaces John Jenkins, who retired two years ago. In Jenkins' absence, Woodcock assumed the role of OND director until a replacement was named.

Stein joined CDER as OND deputy director in 2016. “Peter has played an instrumental role in driving this long-term process of continuous improvement, which focuses on therapeutic and disciplinary alignment of our offices and divisions, workload management, operational efficiency, and staff development and advancement,” Woodcock says. “Making our drug review processes more standardized, functional, and effective is especially important as we address multiple congressional mandates and rapidly evolving science.”

Previously, Stein served as vice president for late stage development, diabetes, and endocrinology at Merck Research Laboratories. He also served as vice president and head of metabolism development at Janssen. He has more than 30 years of academic, clinical, and industry experience, with a focus on metabolism and endocrinology product research and development. He has a medical degree from University of Pennsylvania in Philadelphia.

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