{"database": "openregs", "table": "federal_register", "rows": [["2016-01682", "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.", "2016-01-28", 2016, 1, "https://www.federalregister.gov/documents/2016/01/28/2016-01682/product-specific-bioequivalence-recommendations-draft-and-revised-draft-guidances-for-industry", "https://www.govinfo.gov/content/pkg/FR-2016-01-28/pdf/2016-01682.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": ["2016-01682"], "units": {}, "query_ms": 0.3976499428972602, "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"}