March 7, 2012

AGDUFA II Negotiations

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

March 7, 2012
9:00 am – 11:30 am

Purpose

• To continue discussions on FDA and Industry perspectives on AGDUFA II reauthorization, including financial proposal and review process improvements.

Participants

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.