ADUFA II 2007 Public Meeting Presentations by x8TY71zU

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									ADUFA
Background

       Comments by Steven D. Vaughn, D.V.M.
 Director, Office of New Animal Drug Evaluation
                            Rockville, Maryland
                                  April 24, 2007
          ADUFA
          Background

                 FDA/CVM is committed to a sustainable
                  world class pre-market review
                  organization ensuring safe and
                  effective new animal drugs to meet
                  therapeutic and production needs.




April 24, 2007         U.S. Food and Drug Administration’s   ADUFA II Public Meeting
                          Center for Veterinary Medicine
          ADUFA
          Background

                 FDA/CVM protects the public health by
                  ensuring an adequate amount of safe
                  and effective new animal drugs to meet
                  the therapeutic and production needs of
                  animals




April 24, 2007          U.S. Food and Drug Administration’s   ADUFA II Public Meeting
                           Center for Veterinary Medicine
          ADUFA
          Background
                This means:
                 1. Protecting the public health which
                    includes human, animal and
                    environmental health
                 2. Employing applicable science to make
                    high quality decisions
                 3. Understanding the economics of the
                    animal health industry

April 24, 2007          U.S. Food and Drug Administration’s   ADUFA II Public Meeting
                           Center for Veterinary Medicine
          ADUFA
          Background
                 1. Efficiently conducting quality reviews
                 2. Keeping unsafe and ineffective drugs off
                    of the market
                 3. Expeditiously approving those drugs that
                    are safe and effective




April 24, 2007          U.S. Food and Drug Administration’s   ADUFA II Public Meeting
                           Center for Veterinary Medicine
                 ADUFA
                 Background
                 ADUFA was developed to fill a need
                  created by a continued flat line budgets
                  and decreasing resources in the face
                  of increasing workload demands
                 ADUFA Authorization Legislation
                  became law on November 18, 2003
                 The first Appropriation Legislation was
                  passed on January 23, 2004
April 24, 2007         U.S. Food and Drug Administration’s   ADUFA II Public Meeting
                          Center for Veterinary Medicine
          ADUFA
          Background
            ADUFA is a program of fees to provide:
            1. an enhanced and predictable review
               performance that meets industry,
               Congressional, and public expectations
            2. revenue collections over a five-year period
               would increase from $5 million in FY 2004 to
               $8 million in FY 2005, and to $10 million in the
               third through fifth and final year of the program
            3. a stable revenue stream through the
               implementation of four fees, each generating
               the same level of income in a given fiscal year

April 24, 2007        U.S. Food and Drug Administration’s   ADUFA II Public Meeting
                         Center for Veterinary Medicine

								
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