FDA proposes revisions to guidance on evaluating antimicrobial animal drugs

Published on December 20, 2022
Hands place a label on an orange bottle of antimicrobial pills

Last week, the U.S. Food and Drug Administration (FDA) issued a draft update to guidance for industry (GFI) #152. GFI #152, Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern, is intended to help assess the risk of antimicrobial resistance in people from the use of a medically important antimicrobial drug in food-producing animals. 

The FDA has stated that the scope and purpose of GFI #152 will remain the same. Proposed updates to the guidance include:

  • Revisions to the risk assessment framework
  • Updated ranking criteria for determining the degree of medical importance of antimicrobial drug classes
  • Revised ranking of antimicrobial drug classes as critically important, highly important, or important based on the newly updated ranking criteria
  • New text to address antimicrobial drugs that are not medically important
  • Updates to the “Exposure” tables
  • Revised definitions in the glossary section

The AVMA anticipates providing comments to the FDA and posting a follow-up communication for veterinary professionals after fully reviewing the draft update to the guidance.

Comments

Add New Comment

Restricted HTML

  • Allowed HTML tags: <a href hreflang> <em> <strong> <cite> <blockquote cite> <code> <ul type> <ol start type> <li> <dl> <dt> <dd> <h2 id> <h3 id> <h4 id> <h5 id> <h6 id>
  • Lines and paragraphs break automatically.
  • Web page addresses and email addresses turn into links automatically.
CAPTCHA
Please verify that you are not a robot.