FDA Policy/General

FDA Re-org Moves Lab Science/Safety Under Commissioner’s Office

Federal Register notice: FDA has announced a restructuring of its Office of the Commissioner (OC), and Office of Operations (OO). The reorganization establishes the Office of Laboratory Science and Safety, and will authorize the consolidation of the laboratory science, safety functions, and program activities across FDA under one organizational component that will report directly to the OC. The Employee Safety and Environmental Management Staff will be realigned from the Office of Safety, Security and Crisis Management to the Office of Laboratory Science and Safety. As a result of the staff realignment the Office of Safety, Security and Crisis Management within the OO will be re-titled to the Office of Security and Emergency Management. The Office of Crisis Management within the newly titled Office of Security and Emergency Management will change its title to the Office of Emergency Management. Additionally, the Office of Security and Emergency Management has established the Emergency Planning, Evaluation, and Exercise Staff, and the Program Operations and Coordination Staff within the Office of Emergency Management. To view the notice, click here.

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