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GUIDANCE DOCUMENT

Diabetic Foot Infections: Developing Drugs for Treatment June 2024

Download the Final Guidance Document Read the Federal Register Notice
Final Level 1 Guidance
Docket Number:
FDA-2023-D-4067
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

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  This guidance finalizes and replaces the draft guidance of the same title issued on October 17, 2023.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2023-D-4067.

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