# M14 General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines - FDA Guidance Document Source: https://www.globalkeysolutions.net/guidances/guidance-document/m14-general-principles-on-plan-design-and-analysis-of-pharmacoepidemiological-studies-that-utilize-real-world-data-for-safety-assessment-of-medicines/90dcd460-563e-47bc-a95b-fd98dc534067 > FDA guidance document: M14 General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines. Issue date: July 05, 2024. Get complete insights and analysis. --- ## Details - Title: M14 General Principles on Plan, Design, and Analysis of Pharmacoepidemiological 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: 2024-07-05 - Comment Close Date: 2024-09-03 - Last Changed: 2024-07-25 - Docket Number: FDA-2024-D-2754 ## Related Documents - [E22 General Considerations for Patient Preference Studies](https://www.globalkeysolutions.net/guidances/guidance-document/e22-general-considerations-for-patient-preference-studies/3b39fdd6-9dd0-4536-9f4d-dc3bddcc1267) - [M4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality](https://www.globalkeysolutions.net/guidances/guidance-document/m4qr2-the-common-technical-document-for-the-registration-of-pharmaceuticals-for-human-use-quality/99d9c6a0-e416-4075-875d-80fbbf761ac7) - [M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol](https://www.globalkeysolutions.net/guidances/guidance-document/m11-technical-specification-clinical-electronic-structured-harmonised-protocol/a64c3fb5-ec8d-43b0-af0e-5170b4319e37)