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GUIDANCE DOCUMENT

Orally Inhaled and Intranasal Corticosteroids: Evaluation of the Effects on Growth in Children March 2007

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2001-D-0137
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance provides recommendations for sponsors of orally inhaled and intranasal corticosteroids regarding the design, conduct, and evaluation of clinical studies to assess the effects of these drug products on growth. The recommendations comprise study design and efficacy and safety issues for: 1) approved drug products whose treatment effect on prepubescent growth has not been adequately characterized, and 2) potential new drug products that could be used in the treatment of allergic rhinitis and/or asthma in children. Although the recommendations in this guidance specifically apply to intranasal and orally inhaled corticosteroids, many of the recommendations can be extended to include evaluation of possible growth effects with other therapies for asthma and allergic rhinitis.

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All written comments should be identified with this document's docket number: FDA-2001-D-0137.

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