U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. For Industry
  3. FDA User Fee Programs
  4. Animal Drug User Fee Act (ADUFA)
  5. August 5, 2014 Meeting Minutes
  1. FDA User Fee Programs

August 5, 2014 Meeting Minutes

ADUFA III Conditional Approval Working Group
Teleconference
August 5, 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)
Christopher Loss Jan Cunningham (Dechra)
Matthew Lucia Denni Day (VetPharm)
Shannon Rutherford Mary Hagler (Bayer), Chair
  Beth Kee (Elanco)
  Jennifer Kelley (Virbac)
  Holger Lehmann (Merck)
  Brett McKusick (Merial)
  Jennifer Rice (Neogen)
  Kim Swisher (BI)
  Kelly Klaus (AHI)

Discussion

  • CVM provided feedback on the Conditional Approval document AHI previously submitted.
  • CVM provided AHI with some points of discussion for conversation at future meetings. There was discussion on what topics will be addressed at the October face-to-face meeting.
  • It was decided that the teleconference meetings would be held monthly, instead of bi-weekly.
  • It was decided the next teleconference will be held in one month, tentatively set for September 9, 2014 from 3-4 PM Eastern. Goals for the October meeting will be discussed.
  • Review of action items.