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  1. FDA-TRACK: Agency-wide Program Performance

FDA-TRACK Newsletter March 2020

FDA-TRACK Releases New PDUFA Performance Dashboards

FDA-TRACK releases new performance dashboards for the Prescription Drug User Fee Act (PDUFA). PDUFA authorizes FDA to assess and collect fees for prescription drug products. FDA dedicates these fees toward expediting the drug development process and the process for the review of human drug applications, including postmarket drug safety activities. 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. Stay tuned to this new webpage for future FDA-TRACK User Fee Program releases and updates.

 

 

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