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  3. Development & Approval Process | Drugs
  4. How Drugs are Developed and Approved
  5. Types of Applications
  6. Abbreviated New Drug Application (ANDA)
  7. Generic Drug Review Dashboard Report
  1. Abbreviated New Drug Application (ANDA)

Generic Drug Review Dashboard Report

NOTE: The quarterly reporting required under GDUFA II section VI(C)(2) of the GDUFA Reauthorization Performance Goals and Enhancements Fiscal Years 2018-2022, supersedes the information provided in the Generic Drug Dashboard Report. The final Generic Drug Review Dashboard Report provides data as of April 1, 2018. The metrics that appeared in the Generic Drug Review Dashboard Report can now be found in the GDUFA II Quarterly Performance report. Additional generic drug program activity metrics are available on the GDUFA Enhanced Accountability and Reporting page.

The Office of Generic Drugs (OGD) voluntarily developed the Generic Drug Review Dashboard Report to provide transparency and communication as the agency implemented the Generic Drug User Fee Amendments of 2012 (GDUFA). OGD’s GDUFA commitments are part of our ongoing efforts to make quality, affordable generic medicines available to the American public.

Generic Drug Review Dashboard Reports

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