ADUFA III Negotiation Meeting Minutes
Animal Health Institute
1325 G St. NW, Suite 700, Washington DC
July 10, 2012
10:00 am – 3:00 pm
To continue the discussion on ADUFA reauthorization (ADUFA III)
|Steve Vaughn, FDA (via phone)||Rich Carnevale, AHI|
|David Wardrop, FDA||Bruce Martin, Bayer (via phone)|
|Roxanne Schweitzer, FDA||Chan Baldwin, Abbott|
|Elizabeth Luddy, FDA||Grace Gowda, Merial|
|Dennis Bensley, FDA||Kathy Vannatta, Elanco (via phone)|
|Petra Garosi, FDA (via phone)||Sam Veluvolu, AHI|
|Yanming Chae, FDA||Tom Schriemer, Pfizer|
ADUFA III Funding
- FDA and Industry have reached tentative agreement on ADUFA III funding necessary to support the ADUFA III performance goals and enhancements.
Proposed ADUFA III Legislation and Performance Goals Letter
- FDA and Industry reviewed the proposed ADUFA III legislation and performance goals.
- FDA will send Industry the revised draft ADUFA III legislation and performance goals letter pertaining to the changes discussed in the meeting.
- FDA communicated the next major steps in the reauthorization process.
Next Meeting Agenda
- Discuss any questions that Industry may have after reviewing the revised ADUFA III legislation and performance goals letter proposal.