FDA launches new PDUFA performance dashboards on FDA-TRACK

Today, the U.S. Food and Drug Administration launched the new Prescription Drug User Fee Act (PDUFA) Performance Dashboards on FDA-TRACK, our Agency’s performance management program. These dashboards offer a more concise, interactive, and visual presentation of some of the data reported in FDA’s legislatively-mandated annual PDUFA Performance Report to Congress.

 

The PDUFA Dashboards reflect the most up-to-date data on the Agency’s PDUFA performance, such as submissions received and actions taken. The dashboards also provide FDA’s FY 2018 performance data and preliminary performance data for FY 2019, as well as results and trends for review goals within the previous five years. FDA’s final PDUFA performance data for FY 2019 will be presented in the FY 2020 PDUFA Performance Report to Congress and referenced in updated versions on FDA-TRACK.

The PDUFA Dashboards and FDA-TRACK demonstrates FDA’s commitment to transparency by providing user-friendly data and graphs on certain PDUFA performance goals. The PDUFA Dashboards are the second set of User Fee Program Performance Dashboards that the Agency has made publicly available; the Biosimilar User Fee Act (BsUFA) Performance Dashboards were published on FDA-TRACK in October 2019 and now provide performance data through September 30, 2019.