Drugs

FDA Re-org Outlines Oncology Center of Excellence Role

Federal Register notice: FDA has announced a new organizational structure for the Office of the Medical Products and Tobacco to establish the Oncology Center of Excellence (OCE) that is intended to optimize an integrated cross-Center regulatory approach and enhance the coordination of medical product development in oncology. The OCE will be responsible, in accordance with an Inter-Center Agreement between OCE, CBER, CDER, and CDRH, for the clinical portion of medical oncology and malignant hematology applications involving drugs, biologics, and devices. Other functions of the OCE include: Harmonization of cancer-specific regulatory approaches; coordination of oncology-specific regulatory science initiatives and outreach; implementation of cross-center oncology-focused meetings; stakeholder engagement to the external community of other government agencies, industry, academia, professional societies, and patient advocacy groups; and communication with international regulatory agencies. 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