{"database": "openregs", "table": "federal_register", "rows": [["2017-21202", "Abbreviated New Drug Applications for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of Recombinant Deoxyribonucleic Acid Origin; Draft Guidance for Industry; Availability", "Notice", "The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin.\" The Federal Food, Drug, and Cosmetic Act (FD&C Act) permits any person to submit to the FDA an abbreviated new drug application (ANDA) to seek approval to market a generic version of a previously approved drug product. This draft guidance is intended to assist potential applicants in determining when an application for a synthetic peptide drug product (specifically glucagon, liraglutide, nesiritide, teriparatide, and teduglutide) that refers to a previously approved peptide drug product of recombinant deoxyribonucleic acid (rDNA) origin should be submitted as an ANDA rather than as new drug application (NDA).", "2017-10-03", 2017, 10, "https://www.federalregister.gov/documents/2017/10/03/2017-21202/abbreviated-new-drug-applications-for-certain-highly-purified-synthetic-peptide-drug-products-that", "https://www.govinfo.gov/content/pkg/FR-2017-10-03/pdf/2017-21202.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Drug Administration", "221,199", "The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin.\" The Federal Food,...", 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": ["2017-21202"], "units": {}, "query_ms": 0.5011148750782013, "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"}