FY 2009 Implementation Activities and Accomplishments
FDA made significant progress on implementation activities during FY 2009, the first year under AGDUFA. 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.
- Guidance Development. Guidance Number 199: Guidance for Industry – Animal Generic Drug User Fees and Fee Waivers and Reductions. This final guidance provided information on the types of fees FDA is authorized to collect under AGDUFA and how to request a waiver or a reduction of these fees. The guidance document is available on the FDA Internet at: Animal & Veterinary Guidance for Industry.
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