federal_register: 2021-20064

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2021-20064 Product-Specific Guidances for Ferric Oxyhydroxide; Revised Draft Guidances for Industry; Availability Notice 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Drug Administration (FDA or Agency) is announcing the availability of revised draft guidances for industry entitled "Draft Guidance for Ferric Oxyhydroxide."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). 2021-09-17 2021 9 https://www.federalregister.gov/documents/2021/09/17/2021-20064/product-specific-guidances-for-ferric-oxyhydroxide-revised-draft-guidances-for-industry-availability https://www.govinfo.gov/content/pkg/FR-2021-09-17/pdf/2021-20064.pdf Health and Human Services Department; Food and Drug Administration 221,199 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Drug Administration (FDA or Agency) is announcing the availability of revised draft guidances for industry entitled "Draft Guidance for Ferric Oxyhydroxide."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...  

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