federal_register: 2016-11855

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2016-11855 Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment; Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment."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 This guidance revises the draft guidance of the same name, issued November 9, 2007, by adding information regarding the St. George's Respiratory Questionnaire (SGRQ). 2016-05-20 2016 5 https://www.federalregister.gov/documents/2016/05/20/2016-11855/chronic-obstructive-pulmonary-disease-developing-drugs-for-treatment-draft-guidance-for-industry https://www.govinfo.gov/content/pkg/FR-2016-05-20/pdf/2016-11855.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment."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...

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