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


Expiration Date: Dec 31, 2025


Credits: None available.

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.


All relevant financial relationships have been mitigated.

By completing the evaluation, you are attesting to watching the presentation in its entirety. A certificate will be immediately provided after submission.

Credits Available


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