Issue Date: June 17, 2024
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Antimicrobial
Status: Final

Diabetic Foot Infections: Developing Drugs for Treatment

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 This guidance finalizes and replaces the draft guidance of the same title issued on October 17, 2023.

Download the Guidance Document