In the wake of publicity and congressional attention to drug safety issues, the Food and Drug Administration (FDA) requested the Institute of Medicine assess the drug safety system. The committee reported that a lack of clear regulatory authority, chronic underfunding, organizational problems, and a scarcity of post-approval data about drugs' risks and benefits have hampered the FDA's ability to evaluate and address the safety of prescription drugs after they have reached the market. Noting that resources and therefore efforts to monitor medications' risk–benefit profiles taper off after approval, The Future of Drug Safety offers a broad set of recommendations to ensure that consideration of safety extends from before product approval through the entire time the product is marketed and used.
- FrontMatter
- Reviewers
- Preface
- Contents
- Summary
- 1 Introduction
- 2 Natural History of a Drug
- 3 A Culture of Safety
- 4 The Science of Safety
- 5 Regulatory Authorities for Drug Safety
- 6 Communicating About Safety
- 7 Resources for the Drug Safety System
- Appendixes
- Appendix A: Moving Target: Changes at FDA During the Course of the Study
- Appendix B: Acronyms
- Appendix C: PDUFA Performance Goals—All Years
- Appendix D: Committee on the Assessment of the US Drug Safety System Meeting Agendas
- Appendix E: Summary: Preventing Medication Errors: Quality Chasm Series, Institute of Medicine
- Appendix F: Committee Biographies
- Index
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