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

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

Slide 3

Sustaining Performance

By wisely managing resources

• making strategic investments to infrastructure

We are committed to improving review efficiency, quality, predictability

Slide 4

Challenges

• Keeping pace with inflation, program costs
• Addressing post-approval safety
• Preparing for electronic submissions
• Staying abreast of science, technology

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

Slide 6

Today’s Goal

We want your comments

1. about ADUFA
2. about program reauthorization

Thank you for coming