ADUFA III Conditional Approval Working Group
January 28, 2015
The in-person 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 – Leader||Jan Cunningham (Dechra) by phone|
|Christopher Loss||Denni Day (VetPharm) by phone|
|John Mussman||Paul Duquette (Phibro)|
|Amy Frankshun||Philip Fowler (Neogen)|
|Stacey Shults||Ernst Heinen (Aratana)|
|Brent Volker||Jennifer Kelley (Virbac)|
|Peter Jaensch||Holger Lehmann (Merck) by phone|
|Jean Recta||Brett McKusick (Merial)|
|Shannon Rutherford||Bob Pollet (Elanco), ADS WG chair|
|Lesley Rausch-Derra (Aratana) by phone|
|Kim Swisher (Boehringer Ingelheim Vetmedica)|
|Tracey Ward (Elanco)|
|Rich Carnevale (AHI)|
|Kelly Klaus (AHI)|
|Patrick Krieger (AHI)|
- The meeting opened with all the attendees introducing themselves.
- The first public meeting will be held March 16, 2015.
- The main focus of the meeting was to discuss the edits provided by AHI to CVM on the draft concept paper document. This document addresses some of the issues to be considered for the expansion of the conditional approval process.
- It was agreed that discussions regarding the draft document would continue during the future teleconference meetings.
- The time and dates for the February and March teleconferences were established.