{"database": "openregs", "table": "federal_register", "rows": [["E8-5083", "Draft Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims; Availability", "Notice", "The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled \"Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims.\" This draft guidance is intended to assist applicants in developing labeling for cardiovascular outcome claims for drugs that are indicated to treat hypertension. Because blood pressure control is well established as beneficial in preventing serious cardiovascular events, FDA believes that the appropriate use of these drugs can be encouraged by making the connection between lower blood pressure and improved cardiovascular outcomes more explicit in labeling. This draft guidance is intended to recommend standard labeling for antihypertensive drugs except where differences are clearly supported by clinical data.", "2008-03-13", 2008, 3, "https://www.federalregister.gov/documents/2008/03/13/E8-5083/draft-guidance-for-industry-on-hypertension-indication-drug-labeling-for-cardiovascular-outcome", "https://www.govinfo.gov/content/pkg/FR-2008-03-13/pdf/E8-5083.pdf", "Health and Human Services Department; Food and Drug Administration", "221,199", "The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled \"Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims.\" This draft guidance is intended to assist applicants in...", null]], "columns": ["document_number", "title", "type", "abstract", "publication_date", "pub_year", "pub_month",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": ["E8-5083"], "units": {}, "query_ms": 0.35582599230110645, "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"}