The “Program” At Half-Time: Report Finds Happy Sponsors, But Tweaks Suggested
This article was originally published in RPM Report
Executive Summary
Drug sponsors are enthusiastic about FDA’s new review “Program” for novel drug and biologic applications. But they also want to see some tweaks to make the review process even more efficient – ideas that are sure to be brought to the PDUFA VI negotiating table. One trouble spot FDA says will be addressed right away: manufacturing facility inspections for Program applications.