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FEDERAL REGISTER · NOTICEJune 17, 2024NOTICE — NO LEGAL EFFECT

Diabetic Foot Infections: Developing Drugs for Treatment; 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 CLOSE—
APPLIES TO · SPEQ TAGDrug
Document type
Notice
Agency
Health and Human Services Department
Published
June 17, 2024
Document number
2024-13237
Docket
FDA-2023-D-4067
ABSTRACT

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Diabetic Foot Infections: Developing Drugs for Treatment." The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of diabetic foot infections (DFI) without concomitant bone and joint involvement. This guidance finalizes and replaces the draft guidance of the same title issued on October 17, 2023.

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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