{"database": "openregs", "table": "federal_register", "rows": [["2013-18236", "Guidance for Industry: Safety Labeling Changes-Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act; Availability", "Notice", "The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled \"Safety Labeling Changes--Implementation of Section 505(o)(4) of the FD&C Act.\" The Food and Drug Administration Amendments Act of 2007 (FDAAA) added new provisions to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) authorizing FDA to require certain drug and biological product application holders to make safety-related labeling changes based upon new safety information that becomes available after the drug or biological product is approved under the FD&C Act or the Public Health Service Act (the PHS Act). This final guidance provides information on the implementation of section 505(o)(4) of the FD&C Act, including a description of the types of safety labeling changes that ordinarily might be required under this section; how FDA plans to determine what constitutes new safety information; the procedures involved in requiring safety labeling changes; and enforcement of the requirements for safety labeling changes.", "2013-07-30", 2013, 7, "https://www.federalregister.gov/documents/2013/07/30/2013-18236/guidance-for-industry-safety-labeling-changes-implementation-of-section-505o4-of-the-federal-food", "https://www.govinfo.gov/content/pkg/FR-2013-07-30/pdf/2013-18236.pdf", "Health and Human Services Department; Food and Drug Administration", "221,199", "The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled \"Safety Labeling Changes--Implementation of Section 505(o)(4) of the FD&C Act.\" The Food and Drug Administration Amendments Act of 2007 (FDAAA)...", 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": ["2013-18236"], "units": {}, "query_ms": 133.94951296504587, "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"}