FDA announces new advancing real-world evidence program

The US Food and Drug Administration (FDA) has announced the  Advancing Real-World Evidence (RWE) Program.

The agency developed the program to improve the quality and acceptability of RWE-based approaches that can meet regulatory requirements in support of labeling for effectiveness (eg, new indications, populations, dosing information) or for meeting post-approval study requirements.

For selected product sponsors, the Advancing RWE Program provides the opportunity to meet with FDA staff in the Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research before protocol development or study initiation - to discuss the use of RWE in medical product development. Oncology applications will include participation from the Oncology Center of Excellence. The Advancing RWE Program is an optional pathway for sponsors submitting RWE proposals; established procedures to engage the agency will continue to be available