FDA Policy/General

FDA Deputy Commissioner Sklamberg Leaves Agency

FDA Global Regulatory Operations and Policy deputy commissioner Howard Sklamberg has left the agency effective 3/3 “to pursue new opportunities.” Sklamberg had reportedly informed former commissioner Robert Califf last September that he planned to leave the agency early this year. Global Regulatory Policy associate commissioner Dara Corrigan will serve as acting deputy commissioner until a replacement is appointed.

Sklamberg replaced John Taylor (see earlier story) 1/2014. He previously served as deputy associate commissioner for regulatory affairs in the Office of Regulatory Affairs (ORA) from 7/2011 until he joined CDER 1/2013. Prior to that, he was director of ORA's Office of Enforcement.

Before coming to the agency, Sklamberg was a federal prosecutor serving as deputy chief of the Fraud and Public Corruption Section in the U.S. Attorney’s Office for the District of Columbia. He currently is an adjunct professor at American University's Washington College of Law, where he teaches courses on congressional investigations and white collar crime.

Sklamberg graduated from Harvard Law School, received a bachelor’s degree in economics and political science from Yale University, and earned a master’s degree from the Fletcher School of Law and Diplomacy.

Gupta Raises Concerns About Overton’s Independence, Ideology

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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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