AGDUFA II Negotiations
Center for Veterinary Medicine (CVM)
Metro Park North, Rockville, MD 20855
March 7, 2012
9:00 am – 11:30 am
- To continue discussions on FDA and Industry perspectives on AGDUFA II reauthorization, including financial proposal and review process improvements.
|Steve Vaughn, CVM||Stephanie Batliner, GADA|
|David Wardrop, CVM||Jennifer Johansson, GADA|
|Roxanne Schweitzer, CVM||Herschel Gaddy, GADA|
|Ken Harshman, CVM||Gerald Macedo, GADA|
|Dennis Bensley, CVM||Ted Sullivan, GADA|
|Petra Garosi, CVM|
|Julie Bailey, CVM|
|Yanming Chae, CVM|
|Alexis Nazario-Negron, OFM|
|Frank Claunts, Consultant|
Industry’s Questions on FDA’s Financial Presentation at the Prior Meeting
- Industry did not have any further questions during this meeting.
FDA and Industry Discussions on Program Enhancements
- FDA and Industry continued with the discussions on the following topics:
- FDA provided cost for reducing review time of Administrative ANADAs to 60 days;
- FDA provided costs for reducing review times of JINAD-P data submissions and/or original ANADAs by 10 days per year;
- FDA provided costs for 90-day JINAD-P data submission reactivation and original ANADA reactivations, and the proposed language in the AGDUFA II performance goals letter; and
- FDA provided cost for proactive review of Type II Veterinary Master File review, and the proposed language in the AGDUFA II performance goals letter.
- FDA and Industry negotiation teams reached tentative agreements (pending ratification) on the following topics:
- FDA provided proposed AGDUFA II performance goals language for Question-based-Review (QbR) process for bioequivalence study submissions;
- FDA provided proposed statutory language for reducing Feed Use Combination product fees; and
- FDA also provided proposed AGDUFA II performance goals languages for 30-day CMC CBE supplements, comparability protocols under JINADs, timely foreign pre-approval inspections, multiple data submissions to the CMC technical section, and timely meetings with industry.
Establishment of Future Agendas
- FDA and Industry agreed to continue discussions on the topics listed above. The next meeting is scheduled for April 11, 2012.