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  1. User Fee Performance Reports

ADUFA Performance Reports

On August 14, 2018, the third reauthorization of the Animal Drug User Fee Act (ADUFA) was signed into law. ADUFA amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) by reauthorizing ADUFA for an additional 5 years (FY 2019 through FY 2023, referred to as ADUFA IV).  ADUFA provides FDA with revenue to enhance the performance and predictability in review times for the animal drug industry and provide FDA with resources to improve its review of applications for new animal drugs, with the result that safe and effective new products will be more readily available.

ADUFA I, ADUFA II, ADUFA III and ADUFA IV

Since the implementation of ADUFA I in 2003, FDA has agreed to pursue a comprehensive set of review performance goals and commitments that seek to improve the timeliness and predictability of the review of new animal drug applications (NADAs) and investigational new animal drug (INAD) submissions.

  • ADUFA I (FY 2004 to FY 2008). ADUFA I established review performance goals for FDA, phased in over a 5-year period. These performance goals ran from FY 2004 through FY 2008 and were intended to achieve progressive, yearly improvements in the process for review of NADAs. FDA agreed to review and act on submissions within shorter periods of time for each year. With increased resources under ADUFA I, FDA was able to commit to and achieve review performance goals that incrementally increased to 90 percent levels.
  • ADUFA II (FY 2009 to FY 2013). Under ADUFA II, a key improvement has been the “end-review amendment” (ERA) process that allows FDA reviewers to work with the drug sponsor to amend certain pending submissions. The ERA process allows FDA to decrease the number of review cycles, ultimately leading to a shorter time for approvals.
  • ADUFA III (FY 2014 to FY 2018).  ADUFA III included comprehensive FDA review performance goals and commitments designed to improve the timeliness and predictability for review of NADAs, supplemental NADAs, and INAD submissions.
  • ADUFA IV (FY 2019 to FY 2023).  ADUFA IV includes a comprehensive set of FDA review performance goals and commitments designed to improve the timeliness and predictability of the review of new animal drug applications (NADAs) and reactivations, supplemental NADAs and reactivations, and investigational new animal drug (INAD) submissions.  ADUFA IV also added new performance goals for validating tissue residue methods and scheduling pre-submission conferences, and reduce review times for two other measures as well as converting to all electronic submissions. Additionally, the reauthorization provides the commitment to implement the US-EU Good Manufacturing Practices Inspection Mutual Recognition Agreement, and provide an expanded pathway for conditional approval.

Annual performance reports are prepared by the Office of Planning in collaboration with FDA’s Center for Veterinary Medicine (CVM).

For additional information on these reports, please contact:

Office of Planning
Food and Drug Administration
10903 New Hampshire Avenue
Building 32, Room 4223
Silver Spring, Maryland 20903-0002
Phone: 301-796-4850
FAX: 301-847-3541

ADUFA Performance Reports

Performance reports for previous years are available in the FDA Archive.

 

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