federal_register: 2012-7456

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2012-7456 Draft Guidance for Industry on Bioequivalence Recommendations for Iron Sucrose Injection; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Bioequivalence Recommendations for Iron Sucrose."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. 2012-03-28 2012 3 https://www.federalregister.gov/documents/2012/03/28/2012-7456/draft-guidance-for-industry-on-bioequivalence-recommendations-for-iron-sucrose-injection https://www.govinfo.gov/content/pkg/FR-2012-03-28/pdf/2012-7456.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Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Bioequivalence Recommendations for Iron Sucrose."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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