Management Challenges for FY 2010
On August 14, 2008 the President signed Public Law 110-316, the Animal Drug User Fee Amendments of 2008 (ADUFA II). ADUFA II amends and reauthorizes animal drug user fees for an additional 5 years, FY 2009 through FY 2013. Letters from the Secretary to the Chairmen of the House Committee on Energy and Commerce and the Senate Committee on Health, Education, Labor and Pensions set forth goals and procedures that FDA will strive to meet over the 5 years of ADUFA II.
To continue to meet the demanding review time goals established under ADUFA II in FY 2010, FDA intends to:
- Provide an “end-review amendment” process that enables FDA reviewers to work with the drug sponsor to amend pending submissions to achieve a complete review decision. The goal is to significantly reduce the number of submission review cycles.
- Improve communications with industry by establishing an electronic submission tool allowing industry to submit drug applications electronically.
- Hold 10 public workshops by the end of FY 2013 on topics that FDA and industry have mutually agreed upon.
- Improve communications by enhancing the timeliness and predictability of foreign pre-approval inspections.
- 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 ADUFA II review time goals.
- Develop and issue guidance to industry to explain current FDA thinking on the new animal drug review process.
- Provide training and educational opportunities for FDA staff to enhance the knowledge base of the review organization.
FDA is committed to improving the efficiency, quality, and predictability of the 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 new animal drug applications and submissions. FDA looks forward to the continued success and significant improvements in the animal drug review process that ADUFA II will help make achievable.