federal_register: 2017-26828

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2017-26828 Gluten in Drug Products and Associated Labeling Recommendations; Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Gluten in Drug Products and Associated Labeling Recommendations." This draft guidance is intended to convey to drug manufacturers FDA's recommendations on how certain oral drug products should be labeled regarding gluten, a matter of interest to individuals with celiac disease. Some individuals with celiac disease have faced difficulty when trying to determine whether specific drug products contain gluten. This draft guidance encourages drug manufacturers to have accurate information about their products' gluten content available so they can respond to questions from consumers and health care professionals. 2017-12-13 2017 12 https://www.federalregister.gov/documents/2017/12/13/2017-26828/gluten-in-drug-products-and-associated-labeling-recommendations-draft-guidance-for-industry https://www.govinfo.gov/content/pkg/FR-2017-12-13/pdf/2017-26828.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Gluten in Drug Products and Associated Labeling Recommendations." This draft guidance is intended to convey to drug manufacturers...  

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