# M14 General Principles on Planning, Designing, Analyzing, and Reporting of Non-interventional Studies That Utilize Real-World Data for Safety Assessment of Medicines – FDA Guidance Source: https://www.keypedia.com/guidances/guidance-document/m14-general-principles-on-planning-designing-analyzing-and-reporting-of-non-interventional-studies-that-utilize-real-world-data-for-safety-assessment-of-medicines/71519a94-61da-456b-b457-b4fbd7c82847 > FDA guidance document: M14 General Principles on Planning, Designing, Analyzing, and Reporting of Non-interventional Studies That Utilize Real-World Data for Safety Assessment of Medicines. Issue date: March 03, 2026. Get complete insights and analysis. --- ## Details - Title: M14 General Principles on Planning, Designing, Analyzing, and Reporting of Non-interventional Studies That Utilize Real-World Data for Safety Assessment of Medicines - Communication Type: Guidance Document - Product Type: drugs - Office Name: Center for Drug Evaluation and Research - Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c - Issue Date: 2026-03-03 - Last Changed: 2026-03-03 - Docket Number: FDA-2024-D-2754 ## Related Documents - [E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports](https://www.keypedia.com/guidances/guidance-document/e2dr1-post-approval-safety-data-definitions-and-standards-for-management-and-reporting-of-individual-case-safety-reports/cb7da201-2ee5-4140-a2ea-b6dc8e2108b1) - [M15 General Principles for Model-Informed Drug Development](https://www.keypedia.com/guidances/guidance-document/m15-general-principles-for-model-informed-drug-development/14c456d2-a084-426f-a4a8-82cdde35dc33) - [Postapproval Pregnancy Safety Studies: Guidance for Industry](https://www.keypedia.com/guidances/guidance-document/postapproval-pregnancy-safety-studies-guidance-for-industry/cc78f1d8-dd8f-4a1d-bd04-224dab7b99ef)