Health Law Daily Wrap Up, CLINICAL RESEARCH—FDA GUIDANCE NOTICES: Symptomatic Nonerosive Gastroesophageal Reflux Disease: Developing Drugs for Treatment; Draft Guidance for Industry; Availability, (Sep 18, 2025)

By WK Editorial Staff

The FDA has announced the availability of a draft guidance for industry entitled “Symptomatic Nonerosive Gastroesophageal Reflux Disease: Developing Drugs for Treatment.”

The draft guidance details FDA’s recommendations on the clinical trials for drugs being developed for the treatment of symptomatic nonerosive gastroesophageal reflux disease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. ( Notice , 90 Fed. Reg. 44828 (Sept. 17, 2025)).

Dates. Submit either electronic or written comments on the draft guidance by November 17, 2025 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.

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