The US Food and Drug Administration (FDA) finalized its guidance for industry on the use of real-world data (RWD) and real-world evidence (RWE) in supporting regulatory decisions for drugs and biologics, offering recommendations for data access and safety monitoring.
The guidance, which was released on 30 August 2023, focuses primarily on non-interventional clinical study designs, such as observational cohort studies and case-control studies. However, it outlines what FDA views as potential uses for RWD in interventional studies conducted under an investigational new drug application. For instance, RWD could be used to identify potential participants for a randomized controlled trial, to select endpoints for study, or as a comparator arm in an externally controlled trial.
The guidance applies to any type of RWD, from registries to medical claims, and includes data on products used in clinical practice under an emergency use authorization, according to FDA…
