New Animal Drugs and New Animal Drug Combination Products-Antimicrobial Drugs

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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.

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