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Zdrowie i gospodarka · 30.08.2017

Product-Specific Guidance for Digoxin; Draft Revised Guidance for Industry; Availability

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or we) is announcing the availability of a draft revised guidance for industry on generic digoxin tablets entitled "Draft Guidance on Digoxin."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.

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