{"database": "openregs", "table": "federal_register", "rows": [["2018-03133", "Regulatory Classification of Pharmaceutical Co-Crystals; Guidance for Industry; Availability", "Notice", "The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled \"Regulatory Classification of Pharmaceutical Co-Crystals.\" This guidance provides applicants planning to submit new drug applications and abbreviated new drug applications with information on the appropriate regulatory classification of pharmaceutical co-crystal solid-state forms. It 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 This guidance finalizes the draft guidance for industry entitled \"Regulatory Classification of Pharmaceutical Co-Crystals\" published in August 2016.", "2018-02-15", 2018, 2, "https://www.federalregister.gov/documents/2018/02/15/2018-03133/regulatory-classification-of-pharmaceutical-co-crystals-guidance-for-industry-availability", "https://www.govinfo.gov/content/pkg/FR-2018-02-15/pdf/2018-03133.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 guidance for industry entitled \"Regulatory Classification of Pharmaceutical Co-Crystals.\" This guidance provides applicants planning to submit new drug applications...", 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": ["2018-03133"], "units": {}, "query_ms": 9.762312052771449, "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"}