U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Acute Bacterial Sinusitis — Developing Antimicrobial Drugs for Treatment
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

Acute Bacterial Sinusitis — Developing Antimicrobial Drugs for Treatment October 2012

Download the Final Guidance Document
Final
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

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

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:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

Back to Top