Management Challenges for FY 2010
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, on certain generic new animal drug products, and on certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs.
FY 2009 is the first year under AGDUFA. To meet the demanding review time goals established under AGDUFA in FY 2010, 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.
• Improve 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.
• Eliminate the backlog associated with abbreviated new animal drug applications (ANADAs) and for generic investigational new animal drug (JINAD) submissions.
FDA is committed to improving the efficiency, quality, and predictability of the new animal generic 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 abbreviated applications for generic new animal drugs and submissions. FDA looks forward to significant improvements in the animal generic drug review process that AGDUFA will help make achievable.