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.
Table of Contents |
skim chapter | |
---|---|---|
Front Matter | i-xiv | |
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 |
The National Academies Press and the Transportation Research Board have partnered with Copyright Clearance Center to offer a variety of options for reusing our content. You may request permission to:
For most Academic and Educational uses no royalties will be charged although you are required to obtain a license and comply with the license terms and conditions.
For information on how to request permission to translate our work and for any other rights related query please click here.
For questions about using the Copyright.com service, please contact:
Copyright Clearance Center
22 Rosewood Drive
Danvers, MA 01923
Tel (toll free): 855/239-3415 (select option 1)
E-mail: info@copyright.com
Web: https://www.copyright.com
Loading stats for The Future of Drug Safety: Promoting and Protecting the Health of the Public...