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U.S. Department of Health and Human Services

For Industry

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ADUFA Background

PowerPoint Version

Slide 1

ADUFA Background

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

ADUFA Presentation Slide 1 Cover Slide

Slide 2

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.

ADUFA Presentation Slide 2

Slide 3

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.

ADUFA Presentation Slide 3

Slide 4

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
ADUFA Presentation Slide 4

Slide 5

ADUFA Background

  • Efficiently conducting quality reviews
  • Keeping unsafe and ineffective drugs off of the market
  • Expeditiously approving those drugs that are safe and effective
ADUFA Presentation Slide 5

Slide 6

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
ADUFA Presentation Slide 6

Slide 7

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
ADUFA Presentation Slide 7