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  1. User Fee Reports

User Fee Financial Reports

For the ADUFA, MDUFA, and PDUFA programs, annual financial reports sent to Congress are required by the Act. The financial reports document how each of the legal conditions specified in each Act was met; the conditions allow the Food and Drug Administration to continue collecting and spending the user fees to support the regulation of drugs and devices.  The reports cover the following for the respective fiscal year:

  • the user fee collections and related expenses
  • the amounts carried forward at the end of the year that remain available to enhance the process for the review of new applications and submissions
  • the percent of fees that were spent on personnel compensation and benefits for staff
  • the percent spent for other operational expenses, including support and infrastructure for the application review process

The funds provided by the Acts are crucial to ensuring that FDA has qualified personnel and the appropriate infrastructure to review new drugs and devices in a timely manner. The availability of these fees makes the FDA better able to strengthen its review process and meet the performance goals established for this program.

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