ADUFA III Conditional Approval Working Group
October 8, 2014
8:30 – 11:30 am
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)|
|Matt Lucia – Leader||Paul Duquette (Phibro)|
|Dragan Momcilovic||Beth Kee (Elanco)|
|John Mussman||Holger Lehmann (Merck)|
|Amy Frankshun||Brett McKusick (Merial)|
|Stacey Shults||Lesley Rausch-Derra (Aratana)|
|Brent Volker||Steve Sutherland (Zoetis)|
|Peter Jaensch||Renee Helms (Drug Safety Alliance)|
|Christopher Loss||Philip Fowler (Neogen)|
|Jennifer Kelley (Virbac)|
|Kelly Klaus (AHI)|
|Jan Cunningham (Dechra)|
- The meeting opened with all the attendees introducing themselves.
- Public meetings will most likely be held in February and August/September, 2015.
- The main focus of the meeting was to discuss the document AHI provided to CVM. This document addresses some of the issues which must be considered for the expansion of the conditional approval process, specifically exclusivity and criteria for acceptance of a drug into the conditional approval process.
- It was agreed that discussions regarding the AHI document would be continued during the November teleconference meeting.
- Review of action items from the previous teleconference in September.