On September 21, 2016, the FDA issued the final, updated version of Guidance for Industry #233 VFD Common Format Questions and Answers.
GFI #233 is meant to provide animal drug sponsors who are seeking approval for use of their drug in or on animal feed as a veterinary feed directive (VFD) drug with a recommended common VFD format that can be used by veterinarians to authorize the use of the sponsor’s drug in feed.
According to the FDA:
The draft guidance describes the requirements for sponsor submission of a VFD to FDA as part of the application process for approval of a new animal drug for use in or on animal feed as a VFD drug, as well as the required and optional information to be included on the VFD. The draft guidance also provides examples that illustrate how a common VFD format might appear and how some of the information on the VFD may be pre-populated by a sponsor. By recommending a common format, the draft guidance is expected to help veterinarians, distributors (including feed mills), and animal producers quickly identify relevant information on a VFD order. A common format is also expected to reduce the risk of a veterinarian making an error or leaving out required information when filling in the form.
Guidance documents represent the FDA’s current thinking on particular topics, policies, and regulatory issues. While “guidance for industry” documents are prepared primarily for industry, they also are used by FDA staff and other stakeholders to understand the agency’s interpretation of laws and policies.
View the full announcement here: http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm474642.htm.