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Zdrowie i gospodarka · 9.11.2007

Draft Guidance for Industry on Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment." This guidance is intended to assist the pharmaceutical industry in designing a clinical development program for new drugs for the treatment of chronic obstructive pulmonary disease (COPD). The emphasis of this guidance is on the assessment of efficacy of a new molecular entity in phase 3 clinical studies of COPD.

Source: Federal Register — Food and Drug AdministrationOpen original release →