In December of 2018, the FDA released a new strategic framework to advance the use of real-world evidence (RWE) to support development of drugs and biologics. The framework serves as the FDA’s roadmap for more fully incorporating real-world data (RWD) and RWE, with the ultimate goal of developing a clear path to ensure RWE solutions are part of drug development and regulatory life cycles. While more guidance will be forthcoming, the agency’s three-part approach focuses on whether RWD is fit for use in decision making, whether methodologies used to generate RWE have adequate scientific evidence to address regulatory decision making, and whether proposed RWE approaches meet established standards for data collection and study monitoring. So how does this framework impact biopharma manufacturers current and future drug development plans? How does this impact current RWE approaches for generating data on safety and effectiveness? And what does this mean for the future of clinical trials? Bruce Feinberg, DO, Vice President and Chief Medical Officer, Cardinal Health Specialty Solutions explores the implications of this framework with key experts across the healthcare continuum.