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FDA Invites Comments on Antibiotic Reduction Proposal

by 5m Editor
16 April 2012, at 9:41am

US - The Food and Drug Administration (FDA) issued three documents relating to the use of antibiotics in food producing animals in Friday's (13 April) Federal Register. Comments on the three documents will be accepted until 12 July 2012.

Last week, FDA announced the availability of a guidance for industry (GFI #209) entitled "The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals." This guidance is intended to inform the public of FDA’s current thinking on the use of medically important antimicrobial drugs in animal agriculture. For more information including how to submit comments, please click here.

FDA also announced the availability of a draft guidance for industry (draft GFI #213) entitled "New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions With GFI #209." The purpose of this document is to provide information to sponsors of certain new animal drug products who are interested in developing revised conditions of use for those products consistent with GFI #209 and to set timelines for stakeholders wishing to comply voluntarily with this guidance. For more information including how to submit comments, please click here.

In addition, FDA made available a draft text for a proposed regulation intended to improve the efficiency of FDA’s Veterinary Feed Directive (VFD) program. FDA says it is making this draft text for a proposal available because of the complex scientific and regulatory issues involved, and because of the potential impact that changes to the VFD regulations may have on stakeholders. To view this draft text and submit comments, click here.

Further Reading

- Go to our previous news item on this story by clicking here.