The Food and Drug Administration’s (FDA) Center for Veterinary Medicine has launched a pilot program to encourage more animal drugs and their active ingredients to be manufactured in the U.S.
The agency said the effort is intended to strengthen the veterinary drug supply chain, reduce the risk of shortages and speed up the review of eligible applications for products made domestically. The pilot also allows companies to identify a second U.S.-based source of active ingredients in their initial application, avoiding the need for a separate post-approval submission.
Based on similar FDA programs for human medicines, the initiative will be monitored and refined as the agency gathers feedback from industry participants and stakeholders.
