{"database": "openregs", "table": "federal_register", "rows": [["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Drug Administration (FDA or Agency) is announcing the availability of revised draft guidances for industry entitled \"Draft Guidance for Ferric Oxyhydroxide.\" The revised draft guidances, when finalized, will provide product-specific recommendations on, among other things, the design of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Drug Administration (FDA or Agency) is announcing the availability of revised draft guidances for industry entitled \"Draft Guidance for Ferric Oxyhydroxide.\" The revised draft guidances, when finalized, will provide product-specific...", null]], "columns": ["document_number", "title", "type", "abstract", "publication_date", "pub_year", "pub_month", "html_url", "pdf_url", "agency_names", "agency_ids", "excerpts", "regulation_id_numbers"], "primary_keys": ["document_number"], "primary_key_values": ["2021-20064"], "units": {}, "query_ms": 0.37458399310708046, "source": "Federal Register API & Regulations.gov API", "source_url": "https://www.federalregister.gov/developers/api/v1", "license": "Public Domain (U.S. Government data)", "license_url": "https://www.regulations.gov/faq"}