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Guidance on Chronic Pulmonary Disease Tool

01/10/2014

Federal Register Notice: FDA is making available a draft guidance for industry entitled Qualification of Exacerbations of Chronic Pulmonary Disease Tool for Measurement of Symptoms of Acute Bacterial Exacerbation of Chronic Bronchitis in Patients with Chronic Obstructive Pulmonary Disease. It provides a statement of qualification for the Exacerbations of Chronic Pulmonary Disease Tool (EXACT) patient-reported outcome instrument and summarizes the concept of interest and context of use for which the tool is qualified through the CDER drug development tool qualification program. To download this guidance, click here. To view this notice, click here.

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