The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a revised draft guidance for industry on generic rifaximin oral tablets entitled ``Draft Guidance on Rifaximin.'' The revised draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new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.
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Product-Specific Guidances for Rifaximin; Revised Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a revised draft guidance for industry on generic rifaximin oral tablets entitled ``Dr...
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82 FR 14003
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“Product-Specific Guidances for Rifaximin; Revised Draft Guidance for Industry; Availability,” thefederalregister.org (March 16, 2017), https://thefederalregister.org/documents/2017-05245/product-specific-guidances-for-rifaximin-revised-draft-guidance-for-industry-availability.