Drugs

RAISE Program Explained

A Reagan-Udall Foundation project, the Real-World Accelerator to Improve the Standard of collection and curation of race and Ethnicity data in healthcare (RAISE) is working to find ways to ensure that race and ethnicity data are included in the real-world data being used to support clinical trials. RAISE is discussed in the Health Equity Forum podcast hosted by the FDA Office of Minority Health and Health Equity.

Foundation research director Carla Rodriguez says that missing race and ethnicity data is not just because people don’t want to report it. “There is certainly overarching distrust in the healthcare system that limits reporting,” she says, “and we must take steps to bridge that gap. But there are also steps all along the data continuum of the healthcare ecosystem that are missed opportunities for collecting and managing race and ethnicity data, and this goes from training staff to ask patients about it to having the appropriate race and ethnicity responses so that patients see themselves represented in those responses…. RAISE is about creating a forum to share solutions that allow all of us to fill in the gaps along the data continuum of the healthcare ecosystem so that we can maximize collection and retention of race and ethnicity data every step along the way, from reporting, collection, curation, all the way to integration.”

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