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U.S. Department of Health and Human Services

For Industry

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April 18, 2012

AGDUFA II Negotiations

Center for Veterinary Medicine (CVM)
Metro Park North, Rockville, MD 20855

April 18, 2012
9:00 am – 10:30 am

Purpose

To review the proposed changes made to the draft statutory language and performance goals letter for AGDUFA II

Participants

FDAIndustry
Steve Vaughn, CVMStephanie Batliner, GADA
David Wardrop, CVMJennifer Johansson, GADA
Roxanne Schweitzer, CVMColin Gray, GADA
Ken Harshman, CVMGerald Macedo, GADA
Julie Bailey, CVMHerschel Gaddy, GADA
Petra Garosi, CVMJames Viseio, GADA 
Yanming Chae, CVMJason Chen, GADA
Frank Claunts, ConsultantTed Sullivan, GADA

 

FDA and Industry reviewed and made edits to the final draft of proposed statutory changes, which reflected AGDUFA II fee revenues and agreements on inflation and workload adjusters.

FDA and Industry reviewed and made edits to the final draft of the AGDUFA II performance goals letter which reflected AGDUFA II agreements on enhancements for the review process.

FDA informed Industry about the next steps moving forward. No future meeting was set at this point. Neither FDA nor Industry Ratifiers have approved the tentative agreements mentioned above at this time.

There were no other substantive proposals, significant controversies, or differences of opinion discussed at this meeting.