{"database": "openregs", "table": "federal_register", "rows": [["2017-21190", "Formal Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants of Complex Products Under Generic Drug User Fee Act; Draft Guidance for Industry; Availability", "Notice", "The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA.\" This draft guidance describes an enhanced pathway for discussions between FDA and a prospective applicant preparing to submit (or an applicant that has submitted) to FDA an abbreviated new drug application (ANDA) for a complex product. Specifically, this draft guidance provides information on requesting and conducting product development meetings, pre-submission meetings, and mid-review-cycle meetings with FDA. This draft guidance will assist applicants in generating and submitting a meeting request and the associated meeting package to FDA for complex products to be submitted under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and as contemplated in the commitments made by FDA in connection with the reauthorization of the Generic Drug User Fee Amendments for Fiscal Years (FYs) 2018-2022 (GDUFA II).", "2017-10-03", 2017, 10, "https://www.federalregister.gov/documents/2017/10/03/2017-21190/formal-meetings-between-the-food-and-drug-administration-and-abbreviated-new-drug-application", "https://www.govinfo.gov/content/pkg/FR-2017-10-03/pdf/2017-21190.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Drug Administration", "221,199", "The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA.\" This draft guidance describes an enhanced...", null]], "columns": ["document_number", "title", "type", "abstract", "publication_date", "pub_year", "pub_month", "html_url",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": ["2017-21190"], "units": {}, "query_ms": 0.3141628112643957, "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"}