Developing real-world data and evidence to support regulatory decision-making

FDA

26 August 2019 - On 3 October, the FDA and the Duke-Margolis Center for Health Policy will hold a conference, Developing Real-World Data and Evidence to Support Regulatory Decision-Making. 

The conference is funded through a cooperative agreement between the FDA and Duke-Margolis and will bring together experts to discuss the role of RWD and RWE in the regulatory decision-making setting.

The conference will examine issues addressed in the Framework for FDA’s Real-World Evidence Program, a 2018 FDA framework that outlines how the agency may use RWD and RWE to make regulatory decisions related to the effectiveness of marketed drug products.

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Michael Wonder

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Michael Wonder