January 26, 2024

APC responds to CVM environmental scan request

APC has submitted responses to an environmental scan request from FDA’s Center for Veterinary Medicine (CVM). This feedback is intended to provide perspective and allow the agency to address weaknesses. It is essential, CVM says, as enforcement of GFI #256 continues to roll out in 2024.

We sent along several suggestions, including increasing transparency around moving nominated bulk drug substances to the positive or negative lists, requiring animal drug manufacturers to include excipients on their product labeling, and developing a robust veterinary drug shortage site to parallel the one for human drugs.