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  1. Animal Drug User Fee Act (ADUFA)

October 8, 2014 Meeting Minutes

ADUFA III Conditional Approval Working Group
Rockville, MD
October 8, 2014
8:30 – 11:30 am

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)
 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)

 Discussion

  • 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.