FDA Policy/General

Former FDA Associate Chief Counsel Joins Ropes & Gray

Former FDA Associate Chief Counsel for Enforcement Beth Weinman has joined Ropes & Gray at its Washington, D.C. office as counsel in the firm’s life sciences and FDA regulatory practice. At FDA, she advised Office of Criminal Investigations agents investigating potential criminal violations and worked with the U.S. Department of Justice to prosecute such matters. She has overseen both civil and criminal cases involving medical products.

Weinman also has experience with qui tam False Claims Act whistleblower cases involving the U.S. Department of Health and Human Services, the Department of Justice and other government agencies. She has also provided counsel on matters involving off-label promotion and other marketing practices, GMP violations, and product recalls and withdrawals.

Weinman has an undergraduate degree from Columbia College, and a law degree from New York University School of Law, where she served as associate editor of the Review of Law and Social Change.

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