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The top documents tagged [valid scientific evidence]
Practical Biostatistics for Clinical Trials: How to Find and Use Your Biostatistician
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Challenges in Using a Formal Decision Analysis Approach to Medical Device Approval Larry Kessler, Sc.D. Director, Office of Science and Engineering Laboratories
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Department of Health and Human Services IVD Validation and Regulation in Rx/Dx Combinations FDA/Industry Statistics Workshop Classifiers in Combination
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U.S. Food and Drug Administration Center for Devices and Radiological Health 2009 Sep 29 Edmonton, Oct 1 Vancouver How does the U.S. FDA Regulate Medical
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Overview of the DEcIDE Research Network Agency for Healthcare Research & Quality Center for Outcomes & Evidence December, 2005 December, 2005
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Gene Pennello, Ph.D. Team Leader, Diagnostics Devices Branch Division of Biostatistics
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1 FDA Evaluation of Prescription Genetic Tests Reena Philip, Ph.D. OIVD/CDRH/FDA March 9, 2011 Molecular and Clinical Genetics Panel for Direct-to-Consumer
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