{"database": "openregs", "table": "federal_register", "rows": [["2015-23571", "Product-Specific Bioequivalence Recommendations; Draft and Revised Draft Guidances for Industry; Availability", "Notice", "The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product- specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled \"Bioequivalence Recommendations for Specific Products\" that explained the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this notice were developed using the process described in that guidance.", "2015-09-21", 2015, 9, "https://www.federalregister.gov/documents/2015/09/21/2015-23571/product-specific-bioequivalence-recommendations-draft-and-revised-draft-guidances-for-industry", "https://www.govinfo.gov/content/pkg/FR-2015-09-21/pdf/2015-23571.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 additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product- specific guidance on the design of BE...", 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": ["2015-23571"], "units": {}, "query_ms": 47.6346550276503, "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"}