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# Many GDUFA Goals Met, Exceeded, FDA Says
- URL: https://www.fdaweb.com/many-gdufa-goals-met-exceeded-fda-says/
- Published: 2016-03-30T12:00:00.000Z
- Updated: 2026-09-14T20:51:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135224

> FDA says that during Fiscal Year 2015, it met or exceeded many of the goals established for the Generic Drug User Fee Amendments (GDUFA) program. The program’s FY 2015 performance [report](http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/PerformanceReports/ucm384247.htm?ref=fdaweb.com) says the agency met or exceeded its hiring goal, exceeded the commitment to respond to 70% of GDUFA 3 controlled correspondence within four months of submission, took action on 82% of the backlog, and brought the average time to approval for prior approval supplements to 96 days. (Controlled correspondence is defined as FDA assistance to drug companies and others on a variety of questions posed as controlled documents, not including citizen petitions, requests for reconsideration, or requests for a stay.)  
>  
> While it is too soon to determine whether FDFA will meet all the GDUFA review goals for FY 2015, the report says, the agency is confident that given its efforts to transform the generic drug program, the GDUFA goals agreed to in the commitment letter will be met.  
>  
> The report presents preliminary data on meeting FY 2015 performance review goals and commitments, and updates the review goal performance for FY 2013 and FY 2014.