Drugs

Medical Evidence Generation Collaborative Integrates Info

Efforts underway in the past year to build a National Medical Evidence Generation Collaborative (EvGen) aim at leveraging previously isolated data systems in a way that ensures that available information collected during healthcare-related activities such as medical research, medical product development, and clinical care, can be brought to bear for the benefit of all. Writing in an FDA Voice online blog post, FDA associate deputy commissioner for medical products and tobacco Rachel Sherman and departing commissioner Robert Califf say that by combining insights, expertise, and technologies from across the spectrum of federal and private health sectors, it will be possible to build a new healthcare environment in which, for example, clinical research is embedded seamlessly within real-world clinical practice to create a cycle of improvement in care and outcomes, otherwise known as a continuously learning healthcare system.

“The vision for EvGen put forward by its many supporters is a momentous opportunity to transform how we approach the myriad decisions that affect different parts of the healthcare system,” they write. “For instance, patients would benefit from a more comprehensive patient-centered and evidence-driven approach that engages them as active participants in care and research. At the same time, practitioners and other healthcare professionals would have access to constantly growing sources of scientific evidence that would enable them to more confidently determine which treatments work best for which patients. And payers would have the information needed to identify which treatments truly provide value to those they cover.”

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