FDA extends comment period for draft guidance on certain antimicrobial drugs

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Officials with the FDA have extended the comment period for draft guidance for industry (GFI) on defining durations for the use of certain antimicrobial drugs for animals, in response to requests from stakeholders. The comment period for Draft GFI #273 is now scheduled to close on January 5, 2024.¹

Draft GFI #273, Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals, was released September 25, 2023. At that time, there were nearly 100 approved applications for animal drugs. The GFI provides recommendations on how sponsors of animal drugs without a defined duration of use can voluntarily establish a defined duration of use for certain antimicrobial therapies that are considered medically important.¹

The affected drugs are approved for administration to food-producing animals.^1,2 Revisions to approved labeling for these products should include defining the duration of use and, where appropriate, provide information for veterinarians that will help them facilitate oversight of the drug’s feeding to animals in a manner consistent with the principles of judicious use.²

According to the FDA, revisions made to the use conditions of affected drugs helps to provide for the continued use of these products and to minimize antimicrobial drug exposure. This GFI aims to support the agency’s judicious use efforts and help mitigate the development of antimicrobial resistance, which is part of the FDA’s 5-year plan launched in 2018 for supporting antimicrobial stewardship in veterinary settings.^1,3

Electronic comments may be submitted to https://www.regulations.gov. Written comments may be mailed to the Dockets Management Staff (HFA305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should include docket number FDA-2023-D-2925.²

References

1. FDA releases draft guidance on defining durations of use for certain medically important antimicrobial drugs for food animals. News release. FDA. Updated November 22, 2023. Accessed November 22, 2023. https://www.fda.gov/animal-veterinary/cvm-updates/fda-releases-draft-guidance-defining-durations-use-certain-medically-important-antimicrobial-drugs
2. FDA Center for Veterinary Medicine. Defining durations of use for approved medically important antimicrobial drugs fed to food-producing animals. Regulations.gov. Accessed November 22, 2023. https://www.regulations.gov/document/FDA-2023-D-2925-0002
3. CVM GFI #273 defining durations of use for approved medically important antimicrobial drugs fed to food-producing animals. FDA Center for Veterinary Medicine. Updated November 22, 2023. Accessed November 22, 2023. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-273-defining-durations-use-approved-medically-important-antimicrobial-drugs-fed-food