The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of acute bacterial otitis media (ABOM). This guidance defines ABOM as “the recent or acute onset of inflammation of the middle ear caused by a bacterial pathogen.” Specifically, this guidance addresses the FDA’s current thinking regarding the overall development program and clinical trial designs for drugs to support an indication for treatment of ABOM.2
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.