Data Standards for Drug & Biological Product Submissions Containing Real-World Data - USFDA

This guidance provides recommendations to sponsors for complying with section 745A(a) of the 30 FD&C Act (21 U.S.C. 379k-1(a)) when submitting RWD as study data in applicable drug submissions. FDA is issuing this guidance as part of its RWE Program and to satisfy, in part, the mandate under section 505F of the FD&C Act (21 U.S.C. 355g) to issue guidance on the use of RWE in regulatory decision-making.

This guidance addresses considerations for the use of data standards currently supported by FDA in applicable drug submissions containing study data derived from RWD sources.

For the purposes of this guidance, FDA defines RWD as data relating to individual patient health status or the delivery of health care routinely collected from a variety of sources.

Examples of RWD include data from electronic health records (EHRs); medical claims data, data from product and disease registries; patient-generated data (including data from in-home-use settings); and data gathered from other sources that can inform on health status, such as mobile devices.