The purpose of this guidance is to assist sponsors in the clinical development of drugs2 for the treatment of acute bacterial sinusitis (ABS). This guidance defines ABS as “inflammation of the paranasal sinuses as a result of the presence of a bacterial pathogen within the sinus space when the duration of illness is less than 4 weeks.”
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.