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.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.