Issue Date: October 1, 2012
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Antimicrobial
Status: Final
Acute Bacterial Exacerbations of Chronic Bronchitis in Patients with Chronic Obstructive Pulmonary Disease: Developing Antimicrobial Drugs for Treatment
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled “Acute Bacterial Exacerbations of Chronic Bronchitis in Patients With Chronic Obstructive Pulmonary Disease: Developing Antimicrobial Drugs for Treatment.” This guidance addresses FDA’s current thinking regarding the overall development program and clinical trial designs for drugs to support an indication for treatment of acute bacterial exacerbations of chronic bronchitis in patients with chronic obstructive pulmonary disease (ABECB-COPD), and finalizes the revised draft guidance issued on August 22, 2008.
Download the Guidance Document
