On August 14, 2008, the 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 2009 through FY 2013, referred to as ADUFA II). 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 and ADUFA II
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.
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
ADUFA Performance Reports
FY 2015 ADUFA Performance Report FY 2014 ADUFA Performance Report FY 2013 ADUFA Performance Report FY 2012 ADUFA Performance Report FY 2011 ADUFA Performance Report FY 2010 ADUFA Performance Report FY 2009 ADUFA Performance Report FY 2008 ADUFA Performance Report FY 2007 ADUFA Performance Report FY 2006 ADUFA Performance Report FY 2005 ADUFA Performance Report FY 2004 ADUFA Performance Report