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» FDA shifts gears on real-world evidence
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From FDAAA to the Cures Act
FDA shifts gears on real-world evidence
Nov. 18, 2019
By
Brian Orelli
No Comments
The FDA has typically used real-world evidence (RWE) as a way of monitoring safety issues post-approval, especially through the Sentinel Initiative, which started in response to the FDA Amendments Act of 2007.
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