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Guidance Issuing OfficeCenter for Drug Evaluation and Research
The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of gastroesophageal reflux disease (GERD) in the pediatric population, encompassing infants, children, and adolescents. Specifically, this guidance addresses the Food and Drug Administration’s (FDA’s) current thinking regarding clinical presentation by age and disease, study populations, endpoints, and clinical pharmacology issues affecting dosing. This draft guidance is intended to serve as a focus for continued discussions among the Division of Gastroenterology and Inborn Errors Products, pharmaceutical sponsors, the academic community, and the public.
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-2017-D-5912.