FDA has presented the fiscal year (FY) 2013 Generic Drug User Fee Amendments of 2012 (GDUFA) Performance Report to the President and Congress. This performance report covers the period of October 1, 2012, through September 30, 2013, and presents FDA’s accomplishments for the first year of GDUFA and expectations for the future.
GDUFA enables FDA to administer critical and measurable enhancements to the performance of the human generic drugs program and bring greater predictability and timeliness to the review of human generic drug applications. It also establishes equivalency between domestic and foreign manufacturers providing human generic products to American consumers by ensuring that all facilities, located anywhere in the world, are inspected with comparable depth and rigor using risk-based approaches.
GDUFA challenges FDA to transform its efforts to regulate the global human generic drug industry to ensure the safety and efficacy of products for American consumers. Its goals are formidable and progress towards achieving them is measured incrementally. Early investments in building infrastructure, hiring and training staff, and designing process improvements will lay the foundation for future program success.
FDA has met all GDUFA program commitments for FY2013 and laid the foundation for future success. We are committed to meeting all GDUFA performance goals while, as always, maintaining a focus on ensuring that safe, effective, and affordable human generic drugs are reviewed in an efficient and predictable time frame.