Drugs

Two-Day Workshop on Oncology Patient Registries

FDA’s Oncology Center of Excellence will host a two-day (8/27-28) virtual public workshop to advance the development of patient registries in oncology, with a focus on the rare childhood brain tumor known as diffuse midline glioma, also referred to as diffuse intrinsic pontine glioma. The workshop is intended to bring together stakeholders from across healthcare, research, regulatory, and patient advocacy communities to examine current registry efforts and explore future strategies aimed at accelerating treatment development.

The first day of the workshop will introduce key concepts in oncology registry development such as the use of common data elements and real-world examples of registries that have played a role in regulatory decision-making for cancer therapies, an agency notice says. On the second day, the focus will narrow to diffuse midline gliomas, highlighting national and international initiatives working to collect and harmonize patient data. The session will include discussions on best practices, data quality standards, and how registries can be better designed to support future therapeutic advancements, the notice says.

Workshop goals include:

Reviewing oncology registries that have successfully supported drug development.
Outlining best practices for data collection and common data elements.
Assessing the current state of national and international diffuse midline glioma registries.
Exploring strategies to ensure registries are designed to meet future regulatory and clinical needs.
Launching a sustained effort to improve registry infrastructure for rare pediatric cancers.

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