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Guidance on Developing Drugs for Chronic Bronchitis in Patients with COPD

10/01/2012

Federal Register Notice: FDA is making available a guidance for industry, Acute Bacterial Exacerbations of Chronic Bronchitis in Patients With Chronic Obstructive Pulmonary Disease: Developing Antimicrobial Drugs for Treatment. It addresses the agency’s current thinking on the overall development program and clinical trial designs for drugs to support an indication for treating acute bacterial exacerbations of chronic bronchitis in patients with chronic obstructive pulmonary disease and finalizes the revised draft guidance issued on 8/22/08. To download this guidance, click here. To view this notice, click here.

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