Drugs

Duke Launches Real-World Evidence Collaborative

The Duke University Margolis Center for Health Policy is launching a Real-World Evidence Collaborative to advance policy development related to the regulatory acceptability of real-world evidence (RWE). A statement says the collaborative will “engage major stakeholders to help advise and guide high priority efforts aimed at improving the development and use of RWE, with the express aim of informing and supporting FDA as it works to meet RWE milestones as established in the 21^st Century Cures Act and the sixth PDUFA.”

The collaborative consists of an advisory group that includes senior representation from medical product developers, payers, research groups, providers, patient networks, and regulators. That group is to steer collaborative working groups and contribute to the collaborative’s recommendations.

Initial projects in the collaborative’s first year are to explore primary considerations for assessing the quality of real-world data (RWD) sources, promising opportunities to improve the credibility of observational study designs, and lessons learned from actual industry experience with RWD- and RWE-enabled regulatory submissions.

The effort is being led by former FDA commissioner and former Centers for Medicare and Medicaid Services administrator Mark McClellan, now Margolis professor of business, medicine, and policy at Duke. Funding for the project comes from the Margolis Family Foundation and a combination of financial and in-kind contributions from Lilly, Genentech, GlaxoSmithKline, Johnson & Johnson, Novartis, and Teva.

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