FDA Policy/General

FDA HQ Environmental Impact Statement

The General Services Administration (GSA) says it will prepare an environmental impact statement (EIS) for a proposed master plan to support a significant staff increase at FDA’s White Oak headquarters. An 8/11 Federal Register notice says that a 1997 EIS analyzed the impacts from consolidation of 5,975 FDA employees at White Oak. A 2005 supplement raised the number of employees to 7,720, while a 2009 EIS analyzed the impacts of increasing the number of employees to 8,889.

“To accommodate future growth and further consolidate FDA operations, GSA is preparing an EIS to assess the impacts of an employee population increase of up to approximately 18,000 employees, over a period of 15 years,” the notice says. “The purpose of the proposed action is to provide a master plan for the FDA campus to accommodate the projected growth. The need for the proposed action is to continue to support FDA headquarters consolidation at White Oak, and provide the necessary office and laboratory space, in order to conduct the complex and comprehensive reviews mandated by Congress.”

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