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GUIDANCE DOCUMENT

Acute Bacterial Exacerbations of Chronic Bronchitis in Patients with Chronic Obstructive Pulmonary Disease: Developing Antimicrobial Drugs for Treatment October 2012

Final
Docket Number:
FDA-2008-D-0419
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

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of chronic bronchitis in patients with chronic obstructive pulmonary disease (ABECB-COPD), and finalizes the revised draft guidance issued on August 22, 2008.


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All written comments should be identified with this document's docket number: FDA-2008-D-0419.