FDA-TRACK: Inspections of Establishments Performance 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.
On this page:
Section 705 of the Food and Drug Administration Safety and Innovation Act (FDASIA) requires FDA to publish annual reports on inspections of establishments registered under section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C) (the Report). The Inspections of Establishments Performance Dashboards (the Dashboards) provide a concise, interactive, and visual presentation of data presented in the Report. Data are provided in the Dashboards below for FY 2024. The Dashboards are not intended to replace the Report and are to be used as a supplemental tool for viewing the data.
The FDA product Centers included in the Dashboards are the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), the Center for Veterinary Medicine (CVM), and the Center for Devices and Radiological Health (CDRH). Definitions of Key Terms are found in Appendix A of the Report.
Drug and Device Establishment Registration
Registered Drug Establishments by Type
Domestic and Foreign Establishment Inspections
Percentage of FDA Budget Used to Fund Establishment Inspections