Regulatory Blog

This blog summarizes two important regulatory guidances from the U.S. Food and Drug Administration (FDA) that support pharmacovigilance and real-world evidence generation: M14: General Principles for Planning, Designing, Analyzing, and Reporting Non-Interventional Studies E2D(R1): Post-approval Safety Data – Definitions and Standards for Management and Reporting of Individual Case Safety Reports Together, these guidances provide a framework for how pharmaceutical companies ge