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

 
• By Brenda Sandburg

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

The US Food and Drug Administration closed out the year with the issuance of two final guidances on the use of real-world data, both of which provide minor changes to draft guidances issued in the fall of 2021.

The final guidance entitled “Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products,” specifies what sponsors should consider in designing a registry or proposing to...

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