Docket Number: FDA-2025-D-0331 Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “Symptomatic Nonerosive Gastroesophageal Reflux Disease: Developing Drugs for Treatment.” The draft guidance details FDA’s recommendations on the clinical trials for drugs being developed for the treatment of symptomatic nonerosive gastroesophageal reflux disease (sGERD) in adults, including considerations for eligibility criteria, trial design features, efficacy evaluations, and safety assessments.
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Food and Drug Administration
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All written comments should be identified with this document’s docket number: FDA-2025-D-0331.
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Content current as of:
09/16/2025
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