Issue Date: April 15, 2022
Issued by: Center for Drug Evaluation and Research,Office of New Drugs
Topic(s): Clinical – Medical
Status: Draft
Celiac Disease: Developing Drugs for Adjunctive Treatment to a Gluten-Free Diet
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Celiac Disease: Developing Drugs for Adjunctive Treatment to a Gluten-Free Diet.” This draft guidance addresses FDA’s recommendations regarding clinical trials for drugs being developed for the treatment of celiac disease as an adjunct to a gluten-free diet in adults.
Download the Guidance Document
