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# Ostroff Praises GDUFA Implementation
- URL: https://www.fdaweb.com/ostroff-praises-gdufa-implementation/
- Published: 2016-02-04T12:00:00.000Z
- Updated: 2026-09-15T02:33:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134680

> FDA acting commissioner **Stephen Ostroff** says that after several years of building a modern generic drug review process, the agency is on track to achieve the kind of success the Generic Drug User Fee Amendments (GDUFA) envisioned. Writing in an *FDA Voice* blog [post](http://blogs.fda.gov/fdavoice/index.php/2016/02/building-a-modern-generic-drug-review-process/?ref=fdaweb.com), Ostroff says that the agency is achieving, and in some instances surpassing, important GDUFA goals, including approval of the first generic versions of an innovator drug.  
>  
> “Over the past three years,” Ostroff writes, “we have approved hundreds of first generics for over 200 new drug products. How? We made substantial program improvements. We solicited nationwide technical input from outside experts and organizations, issued a public-facing, transparent prioritization policy, formed a team to expedite the review of first generics, trained review staff, and enhanced our computer systems to streamline the process. We’ve also eliminated our filing backlog of ANDAs.”  
>  
> According to Ostroff, the cumulative result of the effort is a “huge increase in the productivity of the generics program.”  
>  
> The agency is currently working with industry and the public on reauthorization of GDUFA 2, Ostroff says, which is scheduled to begin in 2017.