💊FDA Draft Guidance for sGERD Drug Development
Symptomatic Nonerosive Gastroesophageal Reflux Disease: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
Summary
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Symptomatic Nonerosive Gastroesophageal Reflux Disease: Developing Drugs for Treatment." The draft guidance details FDA's recommendations on the clinical trials for drugs being developed for the treatment of symptomatic nonerosive gastroesophageal reflux disease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.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The draft guidance introduces specific regulatory requirements for developing drugs for symptomatic nonerosive gastroesophageal reflux disease (sGERD), impacting compliance for pharmaceutical companies. The implications extend to trial design, efficacy evaluations, and safety assessments, representing a substantial shift in how drug developers must approach clinical trials for sGERD.