U.S. flag An official website of the United States government
  1. Home
  2. For Industry
  3. FDA User Fee Programs
  4. Animal Drug User Fee Act (ADUFA)
  5. January 28, 2015 Meeting Minutes
  1. Animal Drug User Fee Act (ADUFA)

January 28, 2015 Meeting Minutes

ADUFA III Conditional Approval Working Group
January 28, 2015

Purpose

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.

Participants

 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)

Discussion

  • 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.
     
Back to Top