federal_register: 2013-26570

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2013-26570 Draft Guidance for Industry on Bioequivalence Recommendations for Iron Sucrose; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Bioequivalence Recommendations for Iron Sucrose." The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for iron sucrose injection. The draft guidance is a revised version of a previously issued draft guidance on the same subject. 2013-11-06 2013 11 https://www.federalregister.gov/documents/2013/11/06/2013-26570/draft-guidance-for-industry-on-bioequivalence-recommendations-for-iron-sucrose-availability https://www.govinfo.gov/content/pkg/FR-2013-11-06/pdf/2013-26570.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Bioequivalence Recommendations for Iron Sucrose." The recommendations provide specific guidance on the design of bioequivalence (BE)...

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