FDA releases new BsUFA performance dashboard on FDA-Track

FDA releases new BsUFA performance dashboard on FDA-Track

The Food and Drug Administration (FDA) released a new Biosimilar User Fee Act (BsUFA) Performance Dashboard on the FDA-Track reporting website to provide more user-friendly and transparent information for the BsUFA performance metric goals. The dashboard provides a concise, interactive, and visual presentation of data that is contained in the FY 2018 BsUFA Performance Report to Congress . The BsUFA Dashboards are not intended to replace the Report and are to be used as a supplemental tool for viewing the data. The BsUFA Dashboards reflect performance on submissions received and actions taken as of September 30, 2018. The BsUFA Dashboards present final performance in meeting BsUFA goals for FY 2017 and preliminary performance for FY 2018. Final BsUFA performance data for FY 2018 will be presented in the FY 2019 BsUFA Report and referenced in updated versions of the BsUFA Dashboards. FDA is dedicated to improving the efficiency, quality, and predictability of biosimilar product review.