On August 14, 2008, AGDUFA was signed into law. AGDUFA amends the FD&C Act by authorizing the first generic animal drug user fee program and provides FDA with resources to enhance the performance of the generic new animal drug review process. In exchange for this authority, AGDUFA requires FDA to pursue a comprehensive set of review performance goals and commitments to improve the timeliness and predictability of generic new animal drug reviews. These review performance goals help to expedite the review of ANADAs and reactivations, supplemental ANADAs, and JINAD submissions. Additionally, FDA agreed to meet increasingly challenging review performance goals for these submissions over 5 years (FY 2009 through FY 2013). This report presents FDA’s implementation activities and accomplishments in FY 2009, the first year of AGDUFA.
FY 2009 Implementation Activities and Accomplishments
FDA made significant progress on implementation activities during FY 2009. Key activities and accomplishments during FY 2009 included:
FDA AGDUFA Backlog. As of September 30, 2009, 79 percent (537 of 680) of the backlog associated with ANADAs and JINAD submissions was eliminated. FDA will update the status of the remaining backlog in the FY 2010 performance report.
FDA Hiring. FDA filled 95 percent (19 of 20) of its generic review and support staff positions.
As of September 30, 2009, FDA has met all review time goals agreed to under AGDUFA. With many submissions still pending review and action, and within review goals, FDA has the potential to exceed all FY 2009 performance goals.
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