Issue Date: September 26, 2023
Issued by: Center for Veterinary Medicine
Topic(s): Premarket, Antimicrobial Resistance, Labeling, New Animal Drug Application (NADA)
Status: Draft
CVM GFI #273 Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals
In September 2018, FDA unveiled a 5-year action plan for supporting antimicrobial stewardship in veterinary settings. This plan builds upon the important steps the Center for Veterinary Medicine (CVM) has already taken to support the judicious use of antimicrobials in animals, and is driven by the concept that medically important antimicrobial drugs should only be used in animals when necessary for the treatment, control, or prevention of specific diseases. This plan includes an action item intended “to ensure that all medically important antimicrobial drugs used in the feed or drinking water of food-producing animals have an appropriately targeted duration of use.” This guidance provides information to sponsors of certain antimicrobial animal drug products who are interested in voluntarily establishing appropriately defined durations of therapeutic administration to food-producing animals where none currently exist. The guidance also proposes timelines for stakeholders wishing to comply voluntarily with this guidance.
Download the Guidance Document
