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Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making: Workshop Report
Authors:
Jonathan R. Davis, Vivian P. Nolan, Janet Woodcock, and Ronald W. Estabrook, Editors; Roundtable on Research and Development of Drugs, Biologics, and Medical Devices, Institute of Medicine
Table of Contents
Front Matter i-xii
Executive Summary 1-6
Introduction 7-12
Presubmission and Submission 13-25
FDA Regulatory Review 26-41
Summary of Issues 42-42
Directions for the Future 43-44
Final Comments 45-50
Appendix A: Workshop Agenda 51-55
Appendix B: Speakers and Panelists 56-58
Appendix C: Workshop Registrants 59-67
Appendix D: Glossary and Acronyms 68-76
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