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Draft Guidance on Assessing Registries to Support Regulatory Decision -USFDAYesterday, the USFDA


Real-World Data (RWD) are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources.

Real-World Evidence (RWE) is the clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of RWD.

The draft guidance provides sponsors and other stakeholders with considerations when either designing a registry or proposing to use an existing registry to support a regulatory decision about a drug’s effectiveness or safety.

The draft guidance provides recommendations for a registry’s fitness-for-use in regulatory decision-making, focusing on attributes of a registry that support the collection of relevant and reliable data.

It also provides considerations when linking a registry to another data source for supplemental information, such as data from medical claims, electronic health records, digital health technologies, or another registry.


Lastly, the guidance provides considerations for supporting the FDA’s review of submissions that include registry data.

This draft guidance is part of a series of guidance’s that FDA has already published, or plans to publish, as part of the agency’s RWE Program and in support of the 21st Century Cures Act and Prescription Drug User Fee Act.  

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