FDA Policy/General

Former FDA Lawyer Joins Faegre Drinker

Former FDA senior regulatory counsel Joy Sharp has joined the law firm Faegre Drinker as counsel in Washington, DC. Sharp recently left the agency after 15 years of service. The law firm said in a release that she “brings a wealth of specialized legal and regulatory knowledge to the table for regulated industry, particularly manufacturers of drugs, biologics, medical devices and combination products; importers of food and other regulated products; and companies seeking to optimize and market platform technologies, secure supply chains and meet quality expectations.”

Faeger Drinker says that while at FDA Sharp provided legal input on drug and biological product policy, including inspectional authority, matters of product jurisdiction, scope of statutory authority, and the applicability of the current regulatory regime to various agency initiatives, such as quality metrics and quality management maturity initiatives.

Sharp has a bachelor’s degree from Johns Hopkins and a law degree from the University of Maryland School of Law.

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