Real-World Data: FDA Expounds On Use Of Registries, Challenges In Standardization

Final guidance on assessing registries notes responsibility of sponsors to ensure reliability of data from other organizations and reduce loss of participants to follow-up, while final guidance on data standards for RWD acknowledges sponsors may have limited access to a study’s data sources.

Real World
FDA issues two final guidances on use of real-world data to generate real-world evidence for drugs and biologics • Source: Shutterstock

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