Lessons on the use of real-world data in medical device research: findings from the National Evaluation System for Health Technology Test-Cases
Aim: Although the US FDA encourages manufacturers of medical devices to submit real-world evidence (RWE) to support regulatory decisions, the ability of real-world data (RWD) to generate evidence suitable for decision making remains unclear. The 2017 Medical Device User Fee Amendments (MDUFA IV), au...
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| Main Authors: | , , , , |
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| Format: | Book |
| Published: |
Becaris Publishing Limited,
2024-08-01T00:00:00Z.
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| Subjects: | |
| Online Access: | Connect to this object online. |
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Internet
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| Call Number: |
A1234.567 |
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| Copy 1 | Available |