M14 General Principles on Planning, Designing, Analyzing, and Reporting of Non-Interventio
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "General Principles on Planning, Designing, Analyzing, and Reporting of Non- interventional Studies That Utilize Real-World Data for Safety Assessment of Medicines." The guidance was prepared under
| Agency | Health and Human Services Department, Food and Drug Administration |
|---|---|
| Document type | Notice |
| Published | 2026-03-04 |
| Summary | The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "General Principles on Planning, Designing, Analyzing, and Reporting of Non- interventional Studies That Utilize Real-World Data for Safety Assessment of Medicines." The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance outlines general principles on planning, designing, analyzing, and reporting non-interventional studies that utilize real-world data for safety assessment of medicines (i.e., drugs, vaccines, and other biological products). The recommendati |
| Document number | 2026-04253 |
| Official record | https://www.federalregister.gov/documents/2026/03/04/2026-04253/m14-general-principles-on-planning-designing-analyzing-and-reporting-of-non-interventional-studies |