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Zdrowie i gospodarka · 20.05.2016

Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment."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 sponsors in designing a clinical development program for new drug products for the treatment of chronic obstructive pulmonary disease (COPD). This guidance revises the draft guidance of the same name, issued November 9, 2007, by adding information regarding the St. George's Respiratory Questionnaire (SGRQ).

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