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Guidance Issuing OfficeCenter 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of chronic bronchitis in patients with chronic obstructive pulmonary disease (ABECB-COPD), and finalizes the revised draft guidance issued on August 22, 2008.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2008-D-0419.