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GUIDANCE DOCUMENT

Celiac Disease: Developing Drugs for Adjunctive Treatment to a Gluten-Free Diet April 2022

Download the Draft Guidance Document Read the Federal Register Notice
Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2021-D-1238
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research, Office of New Drugs
Center for Biologics Evaluation and Research

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Celiac Disease: Developing Drugs for Adjunctive Treatment to a Gluten-Free Diet.” This draft guidance addresses FDA’s recommendations regarding clinical trials for drugs being developed for the treatment of celiac disease as an adjunct to a gluten-free diet in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.

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Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2021-D-1238.

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