FDA (CDER)
GUIDANCE FINAL
M14 General Principles on Planning, Designing, Analyzing, and Reporting of Non-interventional Studies That Utilize Real-World Data for Safety Assessment of Medicines
Published: 3/3/2026Detected: 3/20/2026
Summary preview
Establishes general principles for planning, conducting, analyzing, and reporting non-interventional (real-world data) studies intended to support safety assessment of medicines, aiming to improve methodological rigor…
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