federal_register: 2017-18386

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2017-18386 Product-Specific Guidance for Digoxin; Draft Revised Guidance for Industry; Availability Notice The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft revised guidance for industry on generic digoxin tablets entitled "Draft Guidance on Digoxin." The guidance, once finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for digoxin tablets. 2017-08-30 2017 8 https://www.federalregister.gov/documents/2017/08/30/2017-18386/product-specific-guidance-for-digoxin-draft-revised-guidance-for-industry-availability https://www.govinfo.gov/content/pkg/FR-2017-08-30/pdf/2017-18386.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or we) is announcing the availability of a draft revised guidance for industry on generic digoxin tablets entitled "Draft Guidance on Digoxin." The guidance, once finalized, will provide...

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