Product-Specific Guidances for Ferric Oxyhydroxide; Revised Draft Guidances for Industry; Availability
Primary source
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Issuing agencies
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of revised draft guidances for industry entitled "Draft Guidance for Ferric Oxyhydroxide." The revised draft guidances, 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 ferric oxyhydroxide oral tablets (previously sucroferric oxyhydroxide) and ferric oxyhydroxide intravenous injectable (previously iron sucrose).
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