Draft Guidance for Industry on the Evaluation of the Effects of Orally Inhaled and Intranasal Corticosteroids on Growth in Children; Availability

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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Evaluation of the Effects of Orally Inhaled and Intranasal Corticosteroids on Growth in Children." The Division of Pulmonary and Allergy Drug Products is providing guidance to industry regarding the design, conduct, and evaluation of clinical trials to evaluate the effects of orally inhaled and intranasal corticosteroids on growth in children. This action is important because of recently implemented class labeling of these products with regard to their impact on growth in children. An assessment of the available data supporting the class labeling action has led to recommendations that all drug products of this class be tested by means of a "growth study." The recommendations in this document can provide adequate and well-controlled data that is consistent among drug products and can be included in product labeling.