Registry and Biorepository Learning Community call [April 27, 2023]
FDA RWD & RWE Draft Guidance Discussion
In recent years, the U.S. Food and Drug Administration has released several draft guidance documents related to real-world data and evidence, including one on registries. The Reagan-Udall Foundation for the FDA will present on important definitions, potential regulatory applications of registry data, and considerations for linking registries with other data sources.