Drugs

OCE Slowed New Projects in 2022

The FDA Oncology Center of Excellence (OCE) slowed its launch of new projects in 2022 to allow existing projects to grow in depth and strength. That’s the analysis from OCE director Richard Pazdur in his message in the 2022 OCE annual report.

“This year,” he writes, “our work examined several ways OCE could leverage its resources to modernize evidence generation in oncology drug development.” He says that with the initiatives that began or were strengthened in 2022, OCE aims to:

ensure that clinical trial participants adequately reflect the demographic representation of patients with cancer for whom the products are intended;
open and complete clinical trials more quickly, using less complex trial designs seeking answers to clinical questions important to patients and their doctors;
explore the potentially more efficient development of drugs for cancers defined by molecular alterations;
reform the dose optimization and dose selection paradigm in oncology drug development to maximize not only the efficacy of a drug but the safety and tolerability as well; and
address the problem of outdated labeling of older oncology drugs by assessing publicly available information that may support updates to FDA-approved product labeling.

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