FDA-TRACK: FDARA Section 903 Real Time Quarterly Reports
On August 18, 2017, the FDA Reauthorization Act (FDARA) (Public Law 115-52) was signed into law. FDARA amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) to revise and extend the user fee programs for human drugs, biologics, generic drugs, medical devices, and biosimilar biological products.
FDARA requires FDA to develop several different kinds of informational documents, including public reports, reports to Congress, communications plans, and others. FDA will post these items here as they become available.
FDARA Section 903, 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 real-time quarterly reports are prepared by FDA’s Performance Management Staff (PMS) in collaboration with the Center for Biologics Evaluation and Research, the Center for Drug Evaluation and Research, and the Center for Devices and Radiological Health.
Prescription Drugs
Report containing data on the number and titles of draft and final guidance; and the number and titles of public meetings held on topics related to the process for the review of human drug applications. (FDARA Section 903(a))
- FY 2026 Q1 Real Time Report - Prescription Drugs (PDF - 232KB)
- FY 2025 Q4 Real Time Report - Prescription Drugs (PDF - 451KB)
Devices
Report containing data on the number and titles of draft and final guidance; and the number and titles of public meetings held on topics related to the process for the review of devices. (FDARA Section 903(b))
- FY 2026 Q1 Real Time Report - Devices (PDF - 232KB)
- FY 2025 Q4 Real Time Report - Devices (PDF - 341KB)
Generic Drugs
Report containing data on the number and titles of draft and final guidance; and the number and titles of public meetings held on topics related to human generic drug activities. (FDARA Section 903(c))
- FY 2026 Q1 Real Time Report - Generic Drugs (PDF - 602KB)
- FY 2025 Q4 Real Time Report - Generic Drugs (PDF - 1.61MB)
Biosimilars
Report containing data on the number and titles of draft and final guidance; and the number and titles of public meetings held on topics related to the process for the review of biosimilars. (FDARA Section 903(d))