What US FDA Real-World Evidence Programme 2018 - RWE Framework for Drug and Biological Products: Real-World Data Sources, Study Designs, Data Standards, Regulatory Submissions and Programme Guidance requires
This regulation outlines the FDA's framework for using real-world data (RWD) and real-world evidence (RWE) to support regulatory decisions for drugs and biological products, including…
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Pillar: Pharmaceuticals & Life Sciences · Authority: U.S. Food and Drug Administration (FDA) · Version: 1.0.1 · Last updated:
Primary source: https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence
SHA-256 integrity: c38d6291a9410d5b26e0c53dd367ab97a73feaaaca7eb84e664dead436e09599
Primary Citations — 5 traced to source
- 21st Century Cures Act of 2016 - Authority for FDA to evaluate use of real-world evidence to support approval of new indications for approved drugs
- Framework for FDA's Real-World Evidence Program - Guidance issued in 2018 for evaluating RWE to support approval under section 505(c) of the FD&C Act
+ 3 more citations (full bibliography, deterministic workflow, actionable schema and crosswalks) included in the vault unlock — $0.01 via Skyfire / L402 / Direct Base USDC.
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