Drugs

Oncology ‘Excellence’ Center Handling Reviews: Pazdur

FDA Oncology Center of Excellence (OCE) director Richard Pazdur says the Center has begun coordinating clinical review of oncology products. Writing in an online American Journal of Managed Care post, Pazdur says that applications are submitted to CDER, CBER, or CDRH and, if appropriate, OCE forms a clinical review team with experts from the three medical product Centers as needed based on the specific application. The review team only makes recommendations on the clinical portion of the application; the medical product Center looks at all other aspects. The Center opened 1/2017 in response to President Barack Obama’s “cancer moonshot” initiative.

“By bridging the various medical product centers of FDA, the OCE is ideally suited to support innovation and address the recognition that multiple treatment and diagnostic options are in the best interest of patients,” Pazdur says. “An important aim of the OCE is to facilitate incorporation of the patient view into regulatory decision making. The OCE’s Patient-Focused Drug Development Program will foster collaboration between FDA, patients, and advocacy groups; nurture research into measurement of the patient experience; and generate science-based recommendations for regulatory policy. An ongoing initiative at the OCE is an effort to modernize and broaden the eligibility criteria for patients enrolling in cancer clinical trials.”

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