FDA Policy/General

Former FDA Attorney Joins Hyman Phelps & McNamara

Former CBER Office of Compliance and Biologics Quality deputy director Mark I. Schwartz has joined Hyman Phelps & McNamara after a 13-year career at the agency in escalating responsibility positions. At FDA, he oversaw two of the Office’s four divisions — Case Management and Inspections and Surveillance. His day-to-day activities included reviewing draft Form-483s, Warning Letters, untitled letters and determinations as to whether a regulatory letter, enforcement action or other action would be warranted. Prior to that, Schwartz was associate chief counsel for biologics and drugs (2008-2012), associate chief counsel for biologics (2005-2008) and associate chief counsel for foods (2003-2005). He has law degrees from Duke University School of Law and l'Université de Sherbrooke (Canada).

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