{"database": "openregs", "table": "federal_register", "rows": [["2014-28256", "Guidance for Industry on Scale-Up Post-Approval Changes: Manufacturing Equipment Addendum; Availability", "Notice", "The Food and Drug Administration (FDA) is announcing the availability of a scale-up and post-approval changes (SUPAC) guidance for industry entitled \"SUPAC: Manufacturing Equipment Addendum.\" This replaces the draft guidance of the same name that combined and superseded \"SUPAC IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms: Manufacturing Equipment Addendum,\" published on January 1, 1999; and \"SUPAC-SS: Nonsterile Semisolid Dosage Forms; Manufacturing Equipment Addendum,\" published as a draft on December 1, 1998. FDA revised the draft manufacturing equipment addenda to remove the equipment examples and to clarify the types of processes being referenced.", "2014-12-02", 2014, 12, "https://www.federalregister.gov/documents/2014/12/02/2014-28256/guidance-for-industry-on-scale-up-post-approval-changes-manufacturing-equipment-addendum", "https://www.govinfo.gov/content/pkg/FR-2014-12-02/pdf/2014-28256.pdf", "Health and Human Services Department; Food and Drug Administration", "221,199", "The Food and Drug Administration (FDA) is announcing the availability of a scale-up and post-approval changes (SUPAC) guidance for industry entitled \"SUPAC: Manufacturing Equipment Addendum.\" This replaces the draft guidance of the same name that...", null]], "columns": ["document_number", "title", "type", "abstract", "publication_date", "pub_year", "pub_month", "html_url",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": ["2014-28256"], "units": {}, "query_ms": 189.06273390166461, "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"}