FDA-TRACK: FDARA Section 903 Real Time Quarterly Dashboards
First enacted in 2012 as part of the Food and Drug Administration Safety and Innovation Act (FDASIA), the FDA User Fee Reauthorization Act of 2022, reauthorizes FDA to assess and collect fees for generic drug products from October 2023 through September 2027. GDUFA is designed to speed the delivery of safe and effective generic drugs to the public and improve upon the predictability of the review process.
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Section 903 of the FDA Reauthorization Act (FDARA), focuses on streamlining and improving consistency in performance reporting and requires the FDA to provide Real Time reporting related to the process for the review of human drugs and biologics, medical devices, generic drugs, and biosimilar biological products (the Report). The FDARA Section 903 Real Time Quarterly Dashboards (FDARA 903 Dashboards) provide a concise, interactive, and visual presentation of data that is presented in the legislatively mandated Report. Data are provided in a cumulative format for FY 2026. The FDARA 903 Dashboards are not intended to replace the Report and are to be used as a supplemental tool for viewing the data.
Prescription Drugs
Devices
Generic Drugs
Biosimilars
Previous Year(s):