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Zdrowie i gospodarka · 16/03/2017

Product-Specific Guidances for Rifaximin; Revised Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a revised draft guidance for industry on generic rifaximin oral tablets entitled "Draft Guidance on Rifaximin." The revised draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new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.

Source: Federal Register — Food and Drug AdministrationOpen original release →