February 28, 2012
AGDUFA II Negotiations
Center for Veterinary Medicine (CVM)
Metro Park North, Rockville, MD 20855
February 28, 2012
9:00 am – 3:00 pm
- To continue discussions on FDA and Industry perspectives on AGDUFA II reauthorization, including financial proposal and review process improvements.
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 Jim Viscio, GADA Petra Garosi, CVM Colin Gray, GADA Julie Bailey, CVM Ted Sullivan, GADA Yanming Chae, CVM Alexis Nazario-Negron, OFM Frank Claunts, Consultant
Industry’s Questions on FDA’s Financial Presentation at the Prior Meeting
- Industry sought clarification around the issue of the inflation adjustment scenarios presented in the prior meeting and fee structure scenarios presented in the prior meeting.
FDA and Industry Discussions on Program Enhancements
- The following program enhancements were discussed by FDA and Industry:
- Appropriate Sentinels. Industry agreed with the FDA’s proposal to keep the same five sentinel submissions for AGDUFA II.
- New Performance Goals for Reactivations. FDA proposed a shorter review time for reactivations of certain submission types. Industry was interested in this proposal and asked FDA to provide a cost estimate to implement this proposal.
- Exploration of an Amendment Process. Industry agreed that, as FDA proposed, shorter timeframes for certain reactivations (as discussed in #2 above) could be used in place of an additional amendment process.
- Timely Pre-approval Inspections. Industry agreed to add FDA’s proposed goals letter language.
- Proactive Review of All Type II Veterinary Master Files and Amendments. FDA and Industry agreed to discuss this idea further at the next negotiations meeting.
- Reduced Review Time Incentive for eSubmitter. Industry agreed with the Agency that implementing these incentives would be cost prohibitive and not provide a large return on investment in terms of time to approval.
- Reduced Fees for Feed Use Combination Products. FDA proposed a 50% reduction in the application fee for these types of products. Industry stated it would take the proposal back to its membership for consideration.
- Multiple Data Submissions to the CMC Technical Section. FDA and Industry agreed to add language regarding exploring this topic and implementing the process during AGDUFA II but no specific performance goals would be tied to this concept.
- Development of a Question-based Review (QbR) process for Bioequivalence (BE) Submissions. FDA and Industry agreed that QbR for BE would be useful and agreed to discuss the idea further in a future meeting.
- Workshops/Training for One Cycle CMC. FDA and Industry agreed that rather than committing to a specific number of workshops in the goals letter, FDA would work with the industry to identify and address training needs.
- Changing the Fee Structure for (b)1 Supplements to (b)2 Applications. Industry understood that this would require a statutory change and would significantly impact the ADUFA program.
- Project Management. FDA’s intention is to provide project management on complex projects without the need for additional language in the goals letter. Industry agreed with FDA’s proposal.
- Scheduling Meetings in a Timely Fashion. FDA and Industry agreed to goals letter language to ensure timely meetings.
Establishment of Future Agendas
- FDA and Industry agreed to continue discussions on the topics listed above. The next meeting is scheduled for March 7, 2012.