FDA releases draft guidance for drugs under development for celiac disease

The FDA has issued a draft guidance for sponsors developing drugs as adjunctive treatment to a gluten-free diet in adults with celiac disease.“Specifically, this guidance addresses the FDA’s current recommendations on clinical trials,” the agency wrote. “This guidance also addresses considerations for eligibility criteria, trial design features, efficacy evaluations, clinical outcome assessments and safety assessments.”The agency noted that the guidance is intended only to provide clarity regarding existing requirements and should be viewed solely asRead More