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Guidance Issuing OfficeCenter 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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2001-D-0137.