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💊FDA Draft Guidance for sGERD Drug Development

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Symptomatic Nonerosive Gastroesophageal Reflux Disease: Developing Drugs for Treatment." The draft guidance details FDA's recommendations on the clinical trials for drugs being developed for the treatment of symptomatic nonerosive gastroesophageal reflux disease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