What Framework for Real-World Evidence Program Guidance 2018 requires
The FDA Real-World Evidence Program Guidance 2018 requires sponsors to submit real-world evidence (RWE) studies that…
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Pillar: Pharmaceuticals & Life Sciences · Authority: U.S. Food and Drug Administration · Version: 1.0.0 · Last updated:
Primary source: https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence
SHA-256 integrity: 5d2ef85cd5df8f2f3e327b863aebaf1d61b9ff7a5f3b0ce9fb8f8a687553680c
Primary Citations — 7 traced to source
- Framework for Real-World Evidence Program Guidance 2018, Section II - Data Sources
- Framework for Real-World Evidence Program Guidance 2018, Section III - Study Design
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