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September 9, 2014 Meeting Minutes

September 9, 2014 Meeting Minutes

ADUFA III Conditional Approval Working Group
Teleconference
September 9, 2014
3:00 – 4:00 pm

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  Jan Cunningham (Dechra)
 Shannon Rutherford  Denni Day (VetPharm)
   Paul Duquette (Phibro)
   Tamara Grisard (Novartis)
   Jennifer Kelley (Virbac)
   Holger Lehmann (Merck)
   Lesley Rausch-Derra (Aratana)
   Steve Sutherland (Zoetis)
   Kim Swisher (BI)
   Kelly Klaus (AHI)

 Discussion

  • AHI provided CVM with a document containing discussion points for this and future meetings.
  • CVM provided AHI with additional information that had been requested at the August 8, 2014, teleconference.
  • AHI and CVM crafted an agenda for the face-to-face meeting scheduled on October 8, 2014, from 8:30 – 11:30 AM Eastern.