{"database": "openregs", "table": "federal_register", "rows": [["2014-29035", "Bioequivalence Recommendations for Budesonide Extended-Release Tablets; Draft Guidance for Industry; Availability", "Notice", "The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled \"Bioequivalence Recommendations for Budesonide Extended-Release Tablets.\" The guidance provides specific recommendations on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for budesonide extended-release tablets.", "2014-12-11", 2014, 12, "https://www.federalregister.gov/documents/2014/12/11/2014-29035/bioequivalence-recommendations-for-budesonide-extended-release-tablets-draft-guidance-for-industry", "https://www.govinfo.gov/content/pkg/FR-2014-12-11/pdf/2014-29035.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Food and Drug Administration", "221,199", "The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled \"Bioequivalence Recommendations for Budesonide Extended-Release Tablets.\" The guidance provides specific recommendations on the design of...", 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": ["2014-29035"], "units": {}, "query_ms": 8.395052049309015, "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"}