Real-World Evidence for Regulatory Decision-Making: Guidance From Around the World
Real-World Evidence for Regulatory Decision-Making: Guidance From Around the World
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Publisher
United States: Elsevier Inc
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Language
English
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Publisher
United States: Elsevier Inc
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AbstractPurposeInterest in leveraging real-world evidence (RWE) to support regulatory decision making for product effectiveness has been increasing globally as evident by the increasing number of regulatory frameworks and guidance documents. However, acceptance of RWE, especially before marketing for regulatory approval, differs across countries. I...
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Full title
Real-World Evidence for Regulatory Decision-Making: Guidance From Around the World
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TN_cdi_proquest_miscellaneous_2630925646
Permalink
https://devfeature-collection.sl.nsw.gov.au/record/TN_cdi_proquest_miscellaneous_2630925646
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ISSN
0149-2918
E-ISSN
1879-114X
DOI
10.1016/j.clinthera.2022.01.012
