Issue Date: October 23, 2013
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Antimicrobial
Status: Final
Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for Treatment
The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of acute bacterial skin and skin structure infections (ABSSSI). Specifically, this guidance addresses the Food and Drug Administration’s (FDA’s) current thinking regarding the overall development program and clinical trial designs for systemic drugs to support an indication for the treatment of ABSSSI. This guidance defines ABSSSI as cellulitis/erysipelas, wound infection, and major cutanenous abscess.
Download the Guidance Document
