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Ozone can cause a variety of symptoms in both healthy people and people with respiratory problems, such as asthma and chronic obstructive pulmonary disease (COPD). Health symptoms include: coughing, chest discomfort, reduced lung function, shortness of breath, and irritation of the eyes, nose and...

This guidance document provides sponsors of subsequent entry inhaled corticosteroid (ICS) products for the treatment of asthma with information on the comparative clinical data requirements in order to establish the safety and effectiveness of their products under Section C.08 of the Food and...