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The future of drug safety : promoting and protecting the health of the public /

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...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor Corporativo: Institute of Medicine (U.S.). Committee on the Assessment of the US Drug Safety System
Otros Autores: Baciu, Alina, Stratton, Kathleen R., Burke, Sheila P.
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Washington, DC : National Academies Press, ©2007.
Temas:
Acceso en línea:Texto completo

MARC

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110 2 |a Institute of Medicine (U.S.).  |b Committee on the Assessment of the US Drug Safety System. 
245 1 4 |a The future of drug safety :  |b promoting and protecting the health of the public /  |c Committee on the Assessment of the US Drug Safety System, Board on Population Health and Public Health Practice, Institute of Medicine of the National Academies ; Alina Baciu, Kathleen Stratton, Sheila P. Burke, editors. 
260 |a Washington, DC :  |b National Academies Press,  |c ©2007. 
300 |a 1 online resource (xii, 332 pages) :  |b illustrations 
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505 0 |a Introduction -- Natural history of a drug -- A culture of safety -- The science of safety -- Regulatory authorities for drug safety -- Communicating about safety -- Resources for the drug safety system. 
588 0 |a Print version record. 
520 |a 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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650 0 |a Pharmaceutical policy  |z United States. 
650 0 |a Drugs  |z United States  |x Safety measures. 
650 1 2 |a Drug Approval 
650 2 2 |a United States Government Agencies 
651 2 |a United States 
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650 6 |a Médicaments  |z États-Unis  |x Sécurité  |x Mesures. 
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650 7 |a POLITICAL SCIENCE  |x Public Policy  |x Social Services & Welfare.  |2 bisacsh 
650 7 |a Drugs  |x Safety measures  |2 fast 
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700 1 |a Baciu, Alina. 
700 1 |a Stratton, Kathleen R. 
700 1 |a Burke, Sheila P. 
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