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About ADUFA I
The Law
This program is similar to the very successful program for human drugs that has been in place for over ten years. Like the Prescription Drug User Fee Act, and the Medical Device User Fee and Modernization Act, this legislation helps FDA expedite and improve its review of applications for new animal drugs so that safe and effective new products will be available more quickly. ADUFA became law in November 2003 and authorized FDA to collect user fees to support efficiencies in the review of new animal drugs in four categories: applications, establishments, products, and sponsors. Under ADUFA, FDA agreed to meet a comprehensive set of performance goals for the review of certain submissions over five years. FDA agreed to review and act on submissions within shorter time periods for each new fiscal year to improve the timeliness and predictability of the review of new animal drug applications and investigational new animal drug submissions. FDA’s first four years under ADUFA have been highly productive and successful. ADUFA contributed $43 million (adjusted for inflation) in user fees over a five year period. Since FY 2004, FDA has met or exceeded all of the review performance goals established under ADUFA. This has been accomplished by such measures as hiring a substantial number of additional FDA staff; developing staff; focusing on business process improvements, and developing and disseminating guidance, policy, and procedural documents. The ADUFA program has enabled the FDA to dramatically reduce its review time of new animal drugs, bringing medications to the market more quickly while maintaining high standards for safety and efficacy. This program is due to expire at the end of the current Fiscal Year (September 30, 2008).
Web Page Updated by hd - September 16, 2008, 11:02 AM ET
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