1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Symptomatic Nonerosive Gastroesophageal Reflux Disease: Developing Drugs for Treatment
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

Symptomatic Nonerosive Gastroesophageal Reflux Disease: Developing Drugs for Treatment Draft Guidance for Industry September 2025

Download the Draft Guidance Document Read the Federal Register Notice
Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

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The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “Symptomatic Nonerosive Gastroesophageal Reflux Disease: Developing Drugs for Treatment.” The draft guidance details FDA’s recommendations on the clinical trials for drugs being developed for the treatment of symptomatic nonerosive gastroesophageal reflux disease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.

Submit Comments

Submit Comments Online

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-2025-D-0331.

Back to Top