FDA-TRACK ADUFA and AGDUFA Newsletter - November 2020
FDA-TRACK Releases New Performance Dashboards for ADUFA and AGDUFA
On October 31, 2020, FDA-TRACK released new performance dashboards for the Animal Drug User Fee Act (ADUFA) and Animal Generic Drug User Fee Act (AGDUFA). The ADUFA and AGDUFA provide the FDA with resources to enhance the performance and predictability of the new animal drug and generic new animal drug review processes, resulting in the approval of safe and effective animal drug products. These dashboards offer a more concise, interactive, and visual presentation of some of the data reported in FDA’s legislatively mandated annual ADUFA and AGDUFA Performance Reports to Congress.
The dashboards present selected data on the Agency’s ADUFA and AGDUFA performance, including submissions received and the percentage of actions taken on time. The dashboards reflect FDA’s final FY 2018 and preliminary FY 2019 performance data, along with results and trends for review goals within the previous five years. The FDA’s final ADUFA and AGDUFA performance data for FY 2019 will be presented in the FY 2020 Performance Reports to Congress and reflected in updated dashboard versions on FDA-TRACK.
The dashboards and FDA-TRACK demonstrate the FDA’s commitment to transparency by providing user-friendly data and graphs on ADUFA and AGDUFA performance goals. These dashboards are the third set of User Fee Program Performance Dashboards that the Agency has made publicly available; the Biosimilar User Fee Act (BsUFA) Performance Dashboards were first published on FDA-TRACK in October 2019 and the Prescription Drug User Fee Act (PDUFA) Performance Dashboards were published in March 2020. Check back to the FDA-TRACK: User Fee Performance webpage for future FDA-TRACK User Fee Program releases and updates.