On April 11, 2012, FDA finalized a guidance document entitled “The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals” (Judicious Use Guidance, GFI #209). That final guidance represents the Agency’s current thinking regarding antimicrobial drugs that are medically important in human medicine and used in food-producing animals. Specifically, the final guidance discusses FDA’s concerns regarding the development of antimicrobial resistance in human and animal bacterial pathogens when medically important antimicrobial drugs are used in food-producing animals in an injudicious manner.
Takeaway: This guidance is intended for sponsors of approved applications for new animal drugs and new animal drug combination products containing medically important antimicrobial new animal drugs for use in or on medicated feed or water of food-producing animals.
The guidance contains information for sponsors of such new animal drugs and combination products to facilitate voluntary changes to the conditions of use for such new animal drugs and combination products consistent with FDA’s recommendations.
