Drugs

FDA’s Cancer Patient-Focused Glossary

The FDA Oncology Center of Excellence (OCE) has published a patient-focused glossary of 37 terms to aid patients in understanding complex clinical trial terminology. Writing in The Oncologist, six OCE staff members describe the process OCE took to develop the glossary.

“The oncology clinical trial terms and definitions used in the glossary were generated from sustained multi-stakeholder engagement that generated rich feedback and discussions through patient workshops, surveys, and focus groups,” the article says. “We hope that this patient-focused glossary will help better inform discussions and decision-making surrounding enrollment and participation in clinical trials, as well as facilitate shared decision-making between patients and healthcare providers when discussing trial results that inform the risks and benefits of FDA-approved therapeutic options.”

A pilot project started in 2018 and in the succeeding years, OCE worked to engage and learn extensively from patients about their needs related to understanding oncology clinical trials and terminology.

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