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October 8, 2014 AHI GCC Meeting Minutes

Animal Health Institute (AHI) Government Communication Committee (GCC) Meeting
Rockville, MD
October 8, 2014

Purpose

The purpose of this discussion was to address a conditional approval in major species question by AHI in regard to the Chemistry, Manufacturing, and Controls (CMC) technical section.

Participants

Center for Veterinary Medicine (CVM) Animal Health Institute (AHI)
Bernadette Dunham Numerous AHI Representatives
from its membership
Steven Vaughn  
Martine Hartogensis  

Discussion

  • Prior to the meeting held on October 8, 2014, AHI had posed a question to CVM representatives regarding the determination by the CVM Conditional Approval Working Group that the CMC Technical Section will not be open for consideration as part of the conditional approval process. At the GCC meeting, CVM responded by affirming this position. Any drug product released in the market, whether approved or conditionally approved, must be manufactured with adequate controls and in compliance with cGMPs to help assure that it is safe for its intended use.