AGDUFA II Negotiations
Center for Veterinary Medicine (CVM)
Metro Park North, Rockville, MD 20855
April 18, 2012
9:00 am – 10:30 am
To review the proposed changes made to the draft statutory language and performance goals letter for AGDUFA II
|Steve Vaughn, CVM||Stephanie Batliner, GADA|
|David Wardrop, CVM||Jennifer Johansson, GADA|
|Roxanne Schweitzer, CVM||Colin Gray, GADA|
|Ken Harshman, CVM||Gerald Macedo, GADA|
|Julie Bailey, CVM||Herschel Gaddy, GADA|
|Petra Garosi, CVM||James Viseio, GADA|
|Yanming Chae, CVM||Jason Chen, GADA|
|Frank Claunts, Consultant||Ted 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.