Drugs

Oncology Center Reports on Progress

The FDA Oncology Center of Excellence (OCE) 2018 annual report describes steps taken to get the Center up and running since its 1/2017 establishment as authorized by the 21^st Century Cures Act. Director Richard Pazdur writes that OCE “has collaborated with FDA’s medical products Centers to expedite many important clinical reviews, including the first two chimeric antigen receptor T-cell therapies for the treatment of advanced hematologic malignancies, and the first approvals of site-agnostic indications. The OCE also created two pilot programs to improve the process of evaluating data and evidence to generate a benefit-risk assessment which informs regulatory decisions: the Real-Time Oncology Review and the Assessment Aid. Our experts have led the development of 12 guidance documents on important aspects of oncology and malignant hematology product development.”

Discussing the need to collaborate with stakeholders, Pazdur says OCE has held more than 60 symposiums bringing academics and key therapeutic leaders to FDA. And it has held two workshops for patient advocates to discuss the important role they can play in oncology product development.

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