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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.
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All written comments should be identified with this document's docket number: FDA-2021-D-1238
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Guidance Issuing OfficeCenter for Drug Evaluation and Research, Office of New DrugsCenter 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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Celiac Disease: Developing Drugs for Adjunctive Treatment to a Gluten-Free Diet.” This draft guidance addresses FDA’s recommendations regarding clinical trials for drugs being developed for the treatment of celiac disease as an adjunct to a gluten-free diet in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.