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

Zusammenfassung

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Orally Inhaled and Intranasal Corticosteroids: Evaluation of the Effects on Growth in Children." This guidance provides recommendations regarding the design, conduct, and evaluation of clinical trials to assess the effects of orally inhaled and intranasal corticosteroids on growth in children. For this class of drug products, measurement of growth is considered a sensitive surrogate of, and an important sentinel for, the potential to cause systemic effects. Growth studies designed and carried out following the recommendations in this guidance can provide adequate and well-controlled data that are consistent among drug products and can be included in product labeling. This guidance finalizes the draft guidance published on November 6, 2001.