{"database": "openregs", "table": "federal_register", "rows": [["2023-28291", "Data Standards for Drug and Biological Product Submissions Containing Real-World Data; Guidance for Industry; Availability", "Notice", "The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Data Standards for Drug and Biological Product Submissions Containing Real- World Data.\" This guidance provides recommendations to sponsors to help support compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) when submitting study data derived from real-world data (RWD) sources in applicable regulatory submissions using standards specified in the Data Standards Catalog. FDA is publishing this guidance as part of a series of guidance documents under its program to evaluate the use of real-world evidence (RWE) in regulatory decision making. This guidance finalizes the draft guidance of the same title issued on October 22, 2021.", "2023-12-22", 2023, 12, "https://www.federalregister.gov/documents/2023/12/22/2023-28291/data-standards-for-drug-and-biological-product-submissions-containing-real-world-data-guidance-for", "https://www.govinfo.gov/content/pkg/FR-2023-12-22/pdf/2023-28291.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 final guidance for industry entitled \"Data Standards for Drug and Biological Product Submissions Containing Real- World Data.\" This guidance provides recommendations...", 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": ["2023-28291"], "units": {}, "query_ms": 0.49991300329566, "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"}