Management Challenges for FY 2012: FY 2011 AGDUFA Financial Report
On August 14, 2008 the President signed Public Law 110-316, the AGDUFA. AGDUFA authorizes FDA to collect user fees for certain abbreviated applications for generic new animal drugs, for certain generic new animal drug products, and from certain generic new animal drug sponsors.
To meet the demanding review time goals established under AGDUFA in FY 2012, FDA plans to:
· Continue progress on management initiatives that include development of standard operating procedures for review processes, scientific policies for review staff, and implementation of a quality business system.
· Maintain staffing necessary to help FDA meet AGDUFA review time goals.
· Develop and issue guidance to industry to explain current FDA thinking on the generic new animal drug review process.
· Provide training and educational opportunities for FDA staff to enhance the knowledge base of the review organization.
· Maintain the absence of backlog associated with abbreviated new animal drug applications (ANADAs) and for generic investigational new animal drug (JINAD) submissions.
· With AGDUFA expiring September 30, 2013, negotiations on the reauthorization of the Animal Generic Drug User Fee Act are currently in progress.
FDA is committed to improving the efficiency, quality, and predictability of the generic new animal drug review process. We are dedicated to exploring new approaches and technologies that offer high quality and cost-effective improvements in FDA’s review of ANADAs and other submissions. FDA looks forward to significant improvements in the generic new animal drug review process that AGDUFA helps make achievable.