FDA: Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data

This guidance describes best practices pertaining to conducting and reporting on pharmacoepidemiologic safety studies that use electronic healthcare data, which include administrative claims data and electronic medical record (EMR) data. The guidance includes recommendations for documenting the design, analysis, and results of pharmacoepidemiologic safety studies to optimize FDA’s review of protocols and final reports that are submitted to the Agency.