• Front Matter R1-R16

• Abstract 1-2

• Summary 3-28

• 1 Introduction 29-60

• 2 Incorporating Benefit and Risk Assessment and BenefitRisk Management into Food and Drug Administration Decision-Making 61-120

• 3 Evidence and Decision-Making 121-168

• 4 Selection and Oversight of Required Postmarketing Studies 169-212

• 5 Synthesis 213-226

• Appendix A: Other Elements of the Food and Drug Administration Amendments Act 227-230

• Appendix B: Committee's Letter Report 231-250

• Appendix C: Open Session Agendas 251-254

• Appendix D: Decision Conferencing and Multicriteria Decision Analysis 255-260

• Appendix E: Benefit and Risk Assessment and Management Plan Document Template 261-268

• Appendix F: Committee Biosketches 269-276

Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs, Institute of Medicine " Appendix C: Open Session Agendas ." Ethical and Scientific Issues in Studying the Safety of Approved Drugs . Washington, DC: The National Academies Press, 2012 .

Please select a format: