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December 2, 2014 Meeting Minutes

December 2, 2014 Meeting Minutes

ADUFA III Conditional Approval Working Group
Teleconference
December 2, 2014

Purpose

The meeting between members of the Conditional Approval 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 Denni Day (VetPharm)
Stacey Shults Philip Fowler (Neogen)
  Holger Lehmann (Merck)
  Bob Pollet (Novartis), Chair
  Steve Sutherland (Zoetis)
  Kelly Klaus (AHI)

 Discussion

  • Introductions
  • Continued discussion in regard to exclusivity, eligibility criteria, and conditional approval withdrawal criteria and associated actions.
  • Discussed the timing for sharing the recommendation document between CVM and AHI.
  • Confirmed the dates for the next teleconference and in-person meetings in January, 2015.