FDA Policy/General

Cooley Hires Ex-FDA Lawyer Nath

Former FDA lawyer Sonia Wadhwa Nath has joined Cooley as a partner in the law firm’s business litigation and healthcare regulatory practice groups based in Washington, DC. A near 12-year agency veteran, she previously served as senior counsel in the Office of the Chief Counsel, handling enforcement cases on regulated products, such as pharmaceuticals, medical devices, conventional foods, dietary supplements, OTC drugs, animal drugs and biologics. She negotiated dozens of civil consent decrees for the government and defended FDA in lawsuits brought by industry. “Nath most recently handled criminal prosecutions involving various FDA-regulated products in her appointed role as special assistant US attorney with the US Attorney’s Office in the Central District of California,” the law firm says.

Nath earned a law and master’s degree in public health from George Washington University, and her undergraduate degree from Princeton. She previously worked at Latham & Watkins before joining FDA.

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