Essential prescribing information format outlined in draft labeling guidance.
This article was originally published in The Gray Sheet
Executive Summary
ESSENTIAL PRESCRIBING INFORMATION FORMAT OUTLINED IN FDA LABELING GUIDANCE draft dated April 15. The goal of a one-page essential prescribing information (EPI) format in device labeling is "to provide an overview and a refresher for those already familiar with the full labeling" and communicate "more effectively with practitioners and users of medical devices" the key elements in device labeling, the agency's Center for Devices and Radiological Health says in the draft guidance.