Public Workshop on Optimizing the Use of Real-World Evidence in Regulatory Decision-Making for Drugs and Biological Products-Looking Forward; Request for Comments

The Food and Drug Administration (FDA or Agency) is announcing a public workshop titled "Optimizing the Use of Real-World Evidence in Regulatory Decision-Making for Drugs and Biological Products--Looking Forward." The purpose of the public workshop is to provide interested parties with an update on FDA's current activities related to real- world evidence (RWE) and to share accomplishments, ongoing challenges, and future opportunities. The public workshop will discuss potential next steps to promote the continued evolution and consistent application of real-world data (RWD) in drug development. This public workshop will be convened and supported by a cooperative agreement between FDA and the Duke University, Duke-Margolis Institute for Health Policy.

Abstract as published in the Federal Register.

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