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U.S. Food and Drug Administration. Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may be outdated. . Steven D. Vaughn, DVM. Director

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U s food and drug administration l.jpg

U.S. Food and Drug Administration

Notice: Archived Document

The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may be outdated.


Steven d vaughn dvm l.jpg

Steven D. Vaughn, DVM

Director

Office of New Animal Drug Evaluation

Center for Veterinary Medicine

U.S. Food & Drug Administration

Rockville, MD 20855


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Guidance for Industry #152

  • Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern

  • October 23, 2003


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Qualitative Risk Assessment

  • Release assessment

    • H, M, L

  • Exposure assessment

    • H, M, L

  • Consequence assessment

    Critically important, Highly important,

    Important


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Assessment outcomes integrated into a RISK ESTIMATION

  • HIGH

  • MEDIUM

  • LOW


  • Login