August 5, 2014 Meeting Minutes
ADUFA III Conditional Approval Working Group
August 5, 2014
3:00 – 4:00 pm
The meeting between members of the Conditional Approval group from CVM and regulated industry to further discuss the expansion of the conditional approval process.
|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)|
- 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.