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  1. Animal Drug User Fee Act (ADUFA)

March 10, 2015 Meeting Minutes

ADUFA III Conditional Approval Working Group
Teleconference
March 10, 2015

Purpose

The meeting between members of the Conditional Approval working group from CVM and regulated industry to further discuss the expansion of the conditional approval process.

Participants

 Center for Veterinary Medicine (CVM)  Animal Health Institute (AHI)
 Matthew Lucia  Jennifer Kelley (Virbac)
 Shannon Rutherford  Dawn Cleaver (Zoetis)
 Christopher Loss  Holger Lehmann (Merck)
 Stacey Shultz  Denni Day (VetPharm)
   Philip Fowler (Neogen)
   Bob Pollet (Elanco), Chair
   Brett McKusick (Merial)
   Jan Cunningham (Dechra)
   Kim Swisher (BI)
   Lesley Rausch-Derra (Aratana)
   Kelly Klaus (AHI)

Discussion

  • Introductions
  • Discussed the concept paper and the CVM recommendation document
  • Discussed the upcoming Public Meeting
  • Planned the next steps in regard to finalizing the concept paper
  • Established the timing for the April teleconference