FDA Policy/General

Former FDA Chief Counsel Joins King & Spalding

Former FDA chief counsel Sheldon Bradshaw and two other partners from Hunton & Williams have joined King & Spalding’s life sciences practice. Bradshaw left FDA in 2007 to join Hunton & Williams. He previously served as Department of Justice (DoJ) Office of Legal Counsel deputy assistant attorney general. Prior to DoJ, he practiced law at Howrey Simon Arnold & White (Washington), and clerked for the Fourth Circuit U.S. Court of Appeals for circuit judge Karen Williams. Bradshaw obtained his law degree from George Washington University School of Law, where he was managing editor for the George Washington Law Review.

Joining Bradshaw at King & Spalding is Gary Messplay and Kyle Sampson. Messplay has been representing pharmaceutical and medical device companies for over 20 years. His practice focuses on the regulation of drugs, biologics, medical devices, food, and tobacco. Prior to joining Hunton & Williams, he served as in-house counsel at Eli Lilly. He has a law degree from Indiana University School of Law.

Sampson specializes his practice on FDA regulatory, compliance and enforcement issues. Before joining Hunton & Williams, he held positions in every branch of the federal government, serving in the White House from 2001 to 2003 as associate counsel to the president, and at DOJ from 2003 to 2007 as a special assistant U.S. attorney. He has a law degree from the University of Chicago Law School.

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