ABSTRACT
The Real World Evidence (RWE) program will include demonstration projects, stakeholder engagement, and input from senior leadership and promote shared learning and consistent application, with issuance of guidance documents to assist drug developers. Both the food and drug administration and the private sector had used RWE and Real World Data even before enactment of the 21st Century Cures Act, in both regulatory and non-regulatory contexts. RWE could substantially reduce the time and cost of commercializing new drugs and medical devices. Although the 21st Century Cures Act focused on drugs, the Agency's first major final guidance on RWE following the Act addressed medical devices. RWE can provide the information which informs precision medicine decisions. The Precision Medicine Committee examines legal issues affecting the rapidly emerging field of precision medicine. Precision medicine utilizes information on an individual's genetics and biomarkers, and environmental and lifestyle factors, to inform decisions on disease prevention and treatment.
