Duke-Margolis Paper Details Strategies to Treat COVID-19
Scott Gottlieb and Mark McClellan Co-Author
Durham, NC— Efficiently launching medical products to combat the current and future outbreaks of COVID-19 requires supporting the Food and Drug...
A new white paper from the Real-World Evidence Collaborative considers how Real-World Evidence can support product effectiveness labeling changes through a totality of evidence approach.
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Starting with the 2019 plan year, Medicare Advantage (MA) plans are able to offer expanded supplemental benefits that support their members’ broader health needs. New regulations and guidance from the Centers for Medicare & Medicaid Services (CMS) allow MA plans to offer benefits that are...
Randomized, blinded, and controlled trials are the gold standard for establishing product effectiveness. However, stakeholders throughout the health care environment (i.e., sponsors, regulators, payers, providers, and patients) are eager to leverage real-world data (RWD) and real-world evidence...
A new paper by the Duke-Margolis Center for Health Policy provides a systematic framework to characterize the reliability of real-world data (RWD) to support fitness for use in drug development and regulation. RWD is information about patient health status and health care delivery routinely...
On June 24, 2019, President Trump released an Executive Order (EO) seeking to empower patient decision-making by promoting transparency on price and quality. The EO dovetails congressional efforts to pass an omnibus legislative bill, the Lower Health Care Costs Act of 2019, which includes...
Changes by the Food and Drug Administration (FDA) to drug safety labeling are an important way to provide patients and providers with the most up-to-date information about a product’s risk. However, too little is known about the impact of these changes on health systems behavior and patient...
Artificial intelligence (AI) systems and applications is now poised to disrupt healthcare, with the potential to improve patient outcomes, reduce costs, and enhance work-life balance for healthcare providers through integration with clinical decision support (CDS) software.
AI-enabled...
