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Guidance Issuing OfficeCenter for Drug Evaluation and Research
The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of diabetic foot infections (DFIs) without concomitant bone and joint involvement. Specifically, this guidance addresses the Food and Drug Administration’s (FDA’s) current thinking regarding the overall development program and clinical trial designs for the development of drugs to support an indication for treatment of DFI. Development of drugs for the treatment of acute bacterial skin and skin structure infections, defined as cellulitis/erysipelas, wound infection, and major cutaneous abscess, is addressed in a separate guidance.