{"database": "openregs", "table": "federal_register", "rows": [["2016-19596", "Regulatory Classification of Pharmaceutical Co-Crystals; Draft Guidance for Industry; Availability", "Notice", "The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Regulatory Classification of Pharmaceutical Co-Crystals.\" This guidance provides applicants planning to submit new drug applications (NDAs) and abbreviated new drug applications (ANDAs) with information on the appropriate regulatory classification of pharmaceutical co-crystal solid-state forms. This guidance also provides information about the data that applicants should submit to support the appropriate classification of a co-crystal as well as the regulatory implications of the classification. This draft guidance revises the guidance for industry entitled \"Regulatory Classification of Pharmaceutical Co- Crystals\" issued in April 2013.", "2016-08-17", 2016, 8, "https://www.federalregister.gov/documents/2016/08/17/2016-19596/regulatory-classification-of-pharmaceutical-co-crystals-draft-guidance-for-industry-availability", "https://www.govinfo.gov/content/pkg/FR-2016-08-17/pdf/2016-19596.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Drug Administration", "221,199", "The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Regulatory Classification of Pharmaceutical Co-Crystals.\" This guidance provides applicants planning to submit new drug...", null]],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": ["2016-19596"], "units": {}, "query_ms": 54.223557002842426, "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"}