Workshop on Draft Guidance on Real-World Data: Electronic Health Records/Medical Claims Data and Data Standards

Meeting Objective

This convening by the Duke-Margolis Center for Health Policy and the U.S. Food and Drug Administration, funded through a cooperative agreement, was an expert workshop where stakeholders discussed and provided clarity on selected common themes derived from public comments on the following draft guidances: ‘Real-World Data: Assessing Electronic Health Records and Medical Claims’ and ‘Data Standards for Drug and Biological Product Submissions Containing Real-World Data.’

Funding Acknowledgement

This workshop is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award U01FD006807 totaling $2,575,023 with 100 percent funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.