AM23-TU-09-O: How Does the FDA Use Real World Data and Real World Evidence? (Enduring)

The FDA uses Real Word Data (RWD) to evaluate biologics. RWD is data relating to patient health status/health care delivery. It may be found in Electronic Health Records (EHRs), claims, registries, etc. RWD-informed benefit-risk assessments (B-RA) have been used for evaluating interventions for SARS-CoV-2, including COVID vaccines and convalescent plasma (CCP). Real World Evidence (RWE) is clinical evidence about the usage and potential benefits/risks of a product and is derived from the analysis of RWD. CBER Biologics Effectiveness and Safety Initiative (BEST) explores RWD to identify and assess exposures to blood, biotherapies, and vaccines and subsequent potential adverse events. We describe types of RWD and how the FDA assesses its relevance/use in evaluating safety and effectiveness. We will show how CBER is using RWD/RWE to support B-RA and consider future directions to enhance the authorization, approval, and safety of CBER-regulated products.