For Industry

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

 FDA Industry
 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.

 

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