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U.S. Department of Health and Human Services

For Industry

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Outlook for the Future of ADUFA

PowerPoint Version

Slide 1

Outlook for the Future of ADUFA

Comments by
Stephen F. Sundlof, D.V.M., Ph.D.
Director, Center for Veterinary Medicine
Animal Drug User Fee Act Public Meeting
Rockville, Maryland
April 24, 2007

Outlook for the Future of ADUFA Slide 1

Slide 2

Building on Success

Performance resulting from added resources

  1. increased staff
  2. new guidance, policies and procedures
  3. augmented management practice
  4. shorter review times
Outlook for the Future of ADUFA Slide 2

Slide 3

Sustaining Performance

By wisely managing resources

  • making strategic investments to infrastructure

We are committed to improving review efficiency, quality, predictability

Outlook for the Future of ADUFA Slide 3

Slide 4

Challenges

  • Keeping pace with inflation, program costs
  • Addressing post-approval safety
  • Preparing for electronic submissions
  • Staying abreast of science, technology
Outlook for the Future of ADUFA Slide 4

Slide 5

ADUFA Benefits

To public…

  1. earlier access to safe, effective drugs

To industry…

  1. predictable review process
  2. greater investment in drug research, development
Outlook for the Future of ADUFA Slide 5

Slide 6

Today’s Goal

We want your comments

  1. about ADUFA
  2. about program reauthorization

Thank you for coming

Outlook for the Future of ADUFA Slide 6