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Guidance on Drug Development for COPD

11/09/2007

Federal Register Notice: FDA is making available a draft guidance for industry, Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment, intended to assist the pharmaceutical industry in designing a clinical development program for new drugs for treating chronic obstructive pulmonary disease (COPD). It emphasizes the assessment of a new molecular entity’s during COPD in Phase 3 clinical studies. To download the guidance, click here. To view this notice, click here.

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