August 5, 2014 Meeting Minutes
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.