Issue Date: September 30, 2012
Issued by: Center for Drug Evaluation and Research
Topic(s):
Status: Final
Guidance for Industry: Acute Bacterial Otitis Media: 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 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
Download the Guidance Document
