Submission of real-world evidence for drugs and biologics: FDA draft guidance

By Dr Nicola Davies

In the wake of the 21st Century Cures Act (Cures Act), the US Food and Drug Administration was tasked with exploring how real-world evidence (RWE) could be incorporated into regulatory decision-making. [1] Although a number of pharmaceutical companies have been incorporating RWD into their research and development efforts for some time, the Cures Act has increased interest in the use of RWD for drug development. [2]

The FDA defines RWE as medical evidence “that supports the usage and potential benefits and/or risks of a medical product.”1 RWD can be data which is patient-generated or sourced from electronic health records (EHRs), medical claims and billing, product disease registries, or mobile devices, and informs on the health status of a patient and/or the delivery of healthcare to that patient. [3]