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White Paper
White Paper
Advancing Treatments to Save Lives and Reduce the Risk of COVID-19
Scott Gottlieb and Mark McClellan
2020
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Adding Real-World Evidence to a Totality of Evidence Approach for Evaluating Marketed Product Effectiveness
Nirosha Mahendraratnam, Kerra Mercon, Joy Eckert, Morgan Romine, Adam Kroetsch, Katherine Frank, Rachel Sherman Gregory Daniel, Mark McClellan
2019
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Understanding the Need for Non-Interventional Studies Using Secondary Data to Generate Real-World Evidence for Regulatory Decision Making, and Demonstrating Their Credibility
Nirosha Mahendraratnam, Joy Eckert, Kerra Mercon, Katherine Frank, Morgan Romine, Adam Kroetsch, Rachel Sherman, Gregory Daniel, Mark McClellan
2019
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Advancing Treatments to Save Lives and Reduce the Risk of COVID-19