Gilead Builds Adherence Trial and Behavior Profiling Data Into Truvada PrEP Approval
This article was originally published in RPM Report
Executive Summary
FDA approval of Gilead’s Truvada for pre-exposure prophylaxis generated national news in advance of the major HIV/AIDS international scientific meeting starting in Washington one week later. As part of the final negotiations to get the approval done in time for the news window, FDA and Gilead worked out an interesting arrangement on post-marketing studies that has broad implications for future sponsors.