federal_register: 2023-28291
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
This data as json
| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 This guidance finalizes the draft guidance of the same title issued on October 22, 2021.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... |