ARTICLE | Politics & Policy
FDA guidance sheds light on including EHR data in trials
July 20, 2018 10:59 PM UTC
In a new guidance, FDA outlined ways to use electronic health record data in clinical trials. The guidance is intended to modernize and streamline trials through the inclusion of real-world data.
The guidance applies to prospective trials of drugs, biological products, medical devices and combination products, plus foreign clinical trials that support a U.S. regulatory application...