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March 31, 2017 Meeting Minutes

March 31, 2017 Meeting Minutes

ADUFA Negotiations with Industry
March 31, 2017
10:00 - 11:00 a.m.
Rockville, MD


Purpose:

The purpose of this meeting was for FDA to propose another alternative to the proposals previously presented.

Participants

FDA

Roxanne Schweitzer, Center for Veterinary Medicine (CVM)
Steve Vaughn, CVM
Cassie Ravo, CVM
David Wardrop, CVM
Beth Luddy, CVM
Julie Bailey, CVM
Cindy Burnsteel, CVM
Chuck Andres, CVM
Dennis Bensley, Jr., CVM
Matt Lucia, CVM
Petra Garosi, CVM
Sharon Tarbell, CVM
Jill Adleberg, Office of Legislation
Lori Talley, Office of Chief Counsel

Industry: Animal Health Institute (AHI)

Rich Carnevale, AHI
Grace Gowda, Merial
Beth Norton, BIVI
Chan Baldwin, Zoetis
Todd Rhodes, Bayer
Kathy Vannatta, Elanco
Sean Parker, Phibro
Kelly Klaus, AHI

FDA presented an additional, alternative proposal for ADUFA IV. Based on previous discussions with AHI, FDA endeavored to include program activities and some enhancements important to Industry. The new proposal, with reduced funding from earlier proposals, would preserve current review timeframes, with the exception of increased time for Manufacturing Supplemental NADAs and Reactivations (Changes Being Effected) and for INAD study Protocols. FDA walked AHI through the other elements of the proposal, providing information on what would and would not be included at this particular funding level.

AHI agreed to review the new proposal, contact FDA with any questions, and provide FDA any counter proposals prior to the next meeting. FDA and AHI agreed to meet again on April 18, 2017, with the goal of reaching agreement on a set of recommendations to put forward for the reauthorization of the ADUFA program.