FDA Policy/General

Ex-FDA Chief Counsel Joins Morrison & Foerster

Former FDA chief counsel Stacy Cline Amin has joined Morrison & Foerster as a partner in its life sciences/healthcare practice. Amin resigned from FDA in January (see story) after almost two and a half years at the helm of the agency’s legal shop. Prior to FDA, she served in the White House as senior associate counsel to the president.

Prior to her administration post, Amin served as chief counsel to the U.S. Senate Committee on Health, Education, Labor and Pensions, and before that as counsel to the U.S. House of Representatives Energy and Commerce Committee. Earlier in her career, she clerked for judge John R. Gibson of the Eighth Circuit Court of Appeals. Amin earned her bachelor’s degree from George Washington University and her law degree from Harvard 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