Real-World Evidence in Support of Oncology Product Registration: A Systematic Review of New Drug Application and Biologics License Application Approvals from 2015–2020
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DOI: 10.1158/1078-0432.ccr-21-2639
Abstract: Real-world evidence (RWE) has garnered great interest to support registration of new therapies and label expansions by the United States Food and Drug Administration (FDA). Currently, practical insights on the design and analysis of regulatory-grade… read more here.
Keywords: application; oncology product; rwe; oncology ... See more keywords