Keywords: Cures Act, Real Word Evidence, Clinical Trial Replication
Under the 21st Century Cures Act the Food and Drug Administration (FDA) is required to develop a framework for a program to evaluate the use of real world evidence (RWE) to help support the approval of a new indication for an approved drug or to satisfy post approval study requirements. This talk will summarize the current state of infrastructure and effort from FDA to understand and utilize real world data and real world evidence.