FDA Publishes Guidance Outlining Drug Safety Studies Using Electronic Health Data

The Food and Drug Administration May 13 announced the availability of guidance for the pharmaceutical industry to use when conducting and analyzing pharmacoepidemiologic safety trials.

FDA will formally publish the guidance May 14, and announce it in a Federal Register notice. The guidance describes the best practices pertaining to conducting and documenting pharmacoepidemiologic safety studies that use electronic health care data, which include administrative claims data and electronic medical record (EMR) data.

The guidance, “Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data,” includes recommendations for documenting the design, analysis, and results of pharmacoepidemiologic safety studies ...