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Front Matter (R1-R14)

Summary (1-14)

1 Introduction (15-30)

2 Natural History of a Drug (31-64)

3 A Culture of Safety (65-104)

4 The Science of Safety (105-150)

5 Regulatory Authorities for Drug Safety (151-176)

6 Communicating About Safety (177-192)

7 Resources for the Drug Safety System (193-204)

Appendix A Moving Target--The Shifting Landscape of Drug Safety in the United States (205-216)

Appendix B Acronyms (217-220)

Appendix C PDUFA Performance Goals All Years (221-254)

Appendix D Committee on the Assessment of the US Drug Safety System Meeting Agendas (255-266)

Appendix E Summary: Preventing Medication Errors: Quality Chasm Series, Institute of Medicine (267-308)

Appendix F Committee Biographies (309-318)

Index (319-332)