This guidance addresses considerations for the use of data standards6 34 currently supported by FDA in applicable drug submissions containing study data7 35 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.
The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law.
FDA guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidance means that something is suggested or recommended, but not required.
FDA GUIDANCE: Data Standards for Drug and Biological Product Submissions Containing Real-World Data