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GUIDANCE DOCUMENT

Pediatric Gastroesophageal Reflux Disease: Developing Drugs for Treatment Guidance for Industry October 2017

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2017-D-5912
Issued by:
Guidance Issuing Office
Center 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 This draft guidance is intended to serve as a focus for continued discussions among the Division of Gastroenterology and Inborn Errors Products, pharmaceutical sponsors, the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.

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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:

Dockets Management
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.

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