Leveraging Real World Data to Support Regulatory Decisions

Real world data (RWD) are available from a broad ecosystem of standardized registries, electronic health records and patient monitoring platforms. The available RWD is reflective of the actual use case scenarios of the healthcare professionals and patients. Real world use case experiences can be leveraged to support regulatory decision making for indication expansion, condition of approval, product surveillance and performance measurement. Transforming registry data into Real World Evidence (RWE) requires an understanding of the available sources, tools and analysis strategy. This session is intended to relate examples of the transformation of RWD from standardized sources such as national registries into RWE to address regulatory decisions. The benefits of leveraging RWE include strengthening regulatory submissions. improving workflow, and can have a positive economic effect. This session will present examples of FDA guidance on the use of RWE, discuss ongoing studies leveraging RWE, and present a perspective on the FDA’s thinking of the use of RWE in medical device review. The session will illustrate the utility of investing in RWE strategy for regulatory decision making.