CORONARY STENT APPROVALS BASED ON SMALL SCALE "SIMILARITY" TRIALS IS UNDER CONSIDERATION BY FDA; CONCEPT IS DISCUSSED AT INDUSTRY-AGENCY MEETING
This article was originally published in The Gray Sheet
Executive Summary
Next-generation coronary stents could be approved based on smaller "similarity" trials by making claims of equivalent rather than superior efficacy compared to existing stents, according to a concept under consideration by FDA. Data for superiority claims could be gathered following approval.