Patient-Focused Drug Development: Moving Up The Development Timeline
This article was originally published in RPM Report
Executive Summary
The patient-focused drug development effort initiated in PDUFA V has been flagged as a success by FDA and industry since it began, and the program is certain to be updated as part of PDUFA VI – if not early as part of the pending 21st Century Cures bill. The key objectives shared by stakeholders: broadening and systematizing patient input, and finding ways to bring it directly into the regulatory process.