Drugs

FDA, Duke Hold Meeting on Real-world Data

FDA and the Duke-Margolis Center for Health Policy will hold a 7/13-14 virtual public meeting to explore potential approaches to developing a high-quality real-world data (RWD) ecosystem. The meeting will discuss “technical challenges and cultural barriers to the scalability of data capture processes, as well as emerging practices being implemented among the stakeholder community,” an agency notice says. It will also discuss ways to strengthen data collection processes through establishing such an ecosystem, including tools, standards, and workflows within and across institutions.

“Existing RWD sources primarily collect information for the delivery or reimbursement of health care services,” the notice says. “Physicians and other health care providers capture data on their patients’ diseases, including their response to therapies, adverse events, and clinical outcomes; however, these data are often not readily accessible and easily standardized. These limitations make it difficult to share data between the clinical and research settings, representing a lost opportunity to capitalize on data already being collected.”

Individuals can register here for the meeting or contact Duke-Margolis Events for more information.

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