federal_register: 2017-05245

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2017-05245 Product-Specific Guidances for Rifaximin; Revised Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a revised draft guidance for industry on generic rifaximin oral tablets entitled "Draft Guidance on Rifaximin." The revised draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for rifaximin oral tablets. 2017-03-16 2017 3 https://www.federalregister.gov/documents/2017/03/16/2017-05245/product-specific-guidances-for-rifaximin-revised-draft-guidance-for-industry-availability https://www.govinfo.gov/content/pkg/FR-2017-03-16/pdf/2017-05245.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a revised draft guidance for industry on generic rifaximin oral tablets entitled "Draft Guidance on Rifaximin." The revised draft guidance, when finalized, will...

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