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The Future of Drug Safety:

Promoting and Protecting the Health of the Public

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Status: Available Now

Size: 348 pages, 6 x 9

Publication Year:2007

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Authors:
Committee on the Assessment of the US Drug Safety System, Alina Baciu, Kathleen Stratton, Sheila P. Burke, Editors
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Description:
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 ...
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Table of Contents
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Front Matter	i-xiv
Summary	1-14	(skim)
1 Introduction	15-30	(skim)
2 Natural History of a Drug	31-64	(skim)
3 A Culture of Safety	65-104	(skim)
4 The Science of Safety	105-150	(skim)
5 Regulatory Authorities for Drug Safety	151-176	(skim)
6 Communicating About Safety	177-192	(skim)
7 Resources for the Drug Safety System	193-204	(skim)
Appendix A Moving Target--The Shifting Landscape of Drug Safety in the United States	205-216	(skim)
Appendix B Acronyms	217-220	(skim)
Appendix C PDUFA Performance Goals All Years	221-254	(skim)
Appendix D Committee on the Assessment of the US Drug Safety System Meeting Agendas	255-266	(skim)
Appendix E Summary: Preventing Medication Errors: Quality Chasm Series, Institute of Medicine	267-308	(skim)
Appendix F Committee Biographies	309-318	(skim)
Index	319-332	(skim)

Description

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.

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