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FEDERAL REGISTER · NOTICEDecember 4, 2024NOTICE — NO LEGAL EFFECT

Evaluating Target Animal Safety and Effectiveness of Antibacterial New Animal Drugs for Bovine Mastitis; Draft Guidance for Industry; Availability

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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.

STATUSNOTICE — NO LEGAL EFFECT
EFFECTIVE—
COMMENTS CLOSEFeb 3, 2025 · closed
APPLIES TO · SPEQ TAGDrugVeterinary
Document type
Notice
Agency
Health and Human Services Department
Published
December 4, 2024
Comments close
February 3, 2025
Document number
2024-28362
Docket
FDA-1993-D-0285
ABSTRACT

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft revised guidance for industry (GFI) #49 entitled "Evaluating Target Animal Safety and Effectiveness of Antibacterial New Animal Drugs for Bovine Mastitis." This draft guidance provides recommendations and considerations for bovine mastitis drug products with antibacterial activity that are administered by intramammary infusion.

Abstract as published in the Federal Register.

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The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.

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