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U.S. Department of Health and Human Services

About FDA

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GDUFA Performance Reports

 
GDUFA was enacted into law on July 9, 2012, as part of the Food and Drug Administration Safety and Innovation Act (FDASIA).  GDUFA is based on an agreement between FDA and the human generic drug industry, codified by Congress, to accelerate the delivery of high-quality, lower-cost human generic drugs.  FDASIA authorizes GDUFA for a 5-year period from October 1, 2012, through September 30, 2017.
 
GDUFA will benefit the American public in numerous ways.  First, it will reduce the time required to review human generic drug applications and enable FDA to make significant progress in clearing a substantial backlog of human generic applications requiring scientific review.  This will make new human generic drugs accessible more quickly.  Second, it will enable FDA to hold all human generic drug manufacturers to the same high-quality standards regardless of location.  Prior to GDUFA, FDA was required to inspect domestic human generic drug manufacturers every 2 years, but no such requirement existed for foreign manufacturers.  This disparity between domestic and foreign manufacturing facilities, combined with insufficient resources, created significant vulnerabilities in the global prescription drug supply chain.  Approximately 80 percent of active ingredients used in human generic medicines and marketed in the United States are manufactured in foreign countries, and more than half of finished products are manufactured overseas.  GDUFA promotes inspection parity between foreign and domestic establishments by ensuring that FDA has the necessary resources to maintain the same high quality oversight standards.
 
Annual performance reports are prepared by FDA’s Office of Planning in collaboration with the Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research.
 
For additional information on these reports, please contact:
Office of Planning
Food and Drug Administration
10903 New Hampshire Avenue
Building 32, Room 4223
Silver Spring, Maryland 20903-0002
Phone: 301-796-4850
FAX: 301-847-3541