The Next Chapter for Real World Evidence: Validating Data with the Patient Voice

In June 2020, in accordance with the 21st Century Cures Act of 2016 and the Prescription Drug User Fee Act (PDUFA), the U.S. Food and Drug Administration (FDA) launched Project Patient Voice. This patient-focused drug development initiative facilitates systematic approaches to collecting and using meaningful patient and caregiver input, to better inform medical product development and regulatory decision-making, taking the use of real-world evidence (RWE) to a new level.