Drugs

FDA Forms Oncology Center of Excellence; Pazdur to Lead

FDA has created an Oncology Center of Excellence (OCE), which was recommended under the Vice President’s National Cancer Moonshot Initiative, to leverage the combined skills of internal regulatory scientists and reviewers with expertise in drugs, biologics and devices to focus on cancer therapies. CDER Office of Hematology and Oncology Drug Products director Richard Pazdur will served as OCE’s acting director. “Dr. Pazdur is the person the FDA needs to get the OCE up and running, because of his in-depth understanding of the inner workings of the FDA, his deep expertise in treating this complex disease and his ability to move the agency forward in this complicated task,” FDA commissioner Robert Califf is quoted in a release as saying.

OCE is charged with expeditig the “development of novel combination products and support an integrated approach to tackle this devastating disease that touches so many American families,” the agency says. “Establishing a Center of Excellence in a disease as complex as cancer requires a thoughtful approach and we recognize that the framework of the OCE will evolve. At the same time, we remain committed to the sense of urgency that is central to the Cancer Moonshot. That is why we determined the best way to accelerate the formation of the OCE without disrupting the ongoing work within the FDA’s centers would be to appoint an internal leader in an acting capacity who can focus on bringing together oncologists across the FDA.”

In leveraging internal expertise to design and implement OCE, FDA says all medical product Center directors “will work alongside Dr. Pazdur in his role as OCE acting director to formalize an innovative, yet seamless cross-center regulatory approach to enhance the coordination of clinical review across oncology-related drugs, biologics and medical devices. The acting director of the OCE will also play a critical role serving as the central point of engagement for oncology stakeholders, including patient-focused advocacy groups, professional associations, industry, academia and sister agencies such as the National Institutes of Health. One of Dr. Pazdur’s charges in his acting role will be to facilitate and streamline this engagement and collaboration.”

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

Read more

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