FrontMatter -- Reviewers -- Preface -- In Memoriam--Dr. Thomas Ten Have -- Contents -- Abstract -- Summary -- 1 Introduction -- 2 Incorporating Benefit and Risk Assessment and Benefit-Risk Management into Food and Drug Administration Decision-Making -- 3 Evidence and Decision-Making -- 4 Selection and Oversight of Required Postmarketing Studies -- 5 Synthesis -- Appendix A: Other Elements of the Food and Drug Administration Amendments Act -- Appendix B: Committee's Letter Report -- Appendix C: Open Session Agendas -- Appendix D: Decision Conferencing and Multicriteria Decision Analysis -- Appendix E: Benefit and Risk Assessment and Management Plan Document Template -- Appendix F: Committee Biosketches.