FDA proposes new antibiotic guidelines

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The Food and Drug Administration has issued a set of proposed guidelines to animal health companies intended to address the concerns of antibiotic resistance. The draft guidelines have been in development for the past three years.

This draft discusses a recommended approach for assessing the safety of new antimicrobial drugs for use in food-producing animals. It specifically focuses on the concerns of antibicrobial resistance of new animal health drugs.

FDA's main safety concern is that use of antimicrobial drugs in food-producing animals may lead to the emergence of disease-causing organisms that may be harmful to humans and that are resistant to drugs used to treat human illness.

In 1998, FDA announced its intention to consider concerns about antimicrobial resistance, in addition to other factors such as drug residues, when evaluating the safety of antimicrobial new animal drugs. In January 1999, FDA published a framework document that outlined possible strategies for managing antimicrobial resistance. The new draft document describes an approach for implementing concepts from the framework document.

The public may submit comments on the draft guidance to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. The full text of the guidelines can be found online at http://www.fda.gov/OHRMS/DOCKETS/98fr/98d-1146-gdl0001.doc.

This document will stay in draft form for 75 days, giving FDA time to collect and analyze public comments about the guidance.

For more news on the draft FDA guidelines, see the Washington Post article, “FDA Combats Resistance to Antibiotics” by clicking here. (James, link to http://www.washingtonpost.com/wp-dyn/articles/A18477-2002Sep14.html)

FDA, Washington Post



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