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 ProductsLooking 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.