September 9, 2014 Meeting Minutes
ADUFA III Conditional Approval Working Group
September 9, 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)|
|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)|
- 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.