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
Autor principal: Institute of Medicine (U.S.).
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: Libro electrónico
Idioma:Inglés
Publicado: Washington, DC : National Academies Press ©2007.
Colección:National Academies ebooks.
Acceso en línea:Conectar con la versión electrónica
Ver en Universidad de Navarra:https://innopac.unav.es/record=b44917934*spi
Descripción
Sumario: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.
Descripción Física:1 recurso electrónico (xii, 332 páginas) : ilustraciones
Formato:Forma de acceso: World Wide Web.
Bibliografía:Incluye referencias bibliográficas e índice.
ISBN:9780309665971
9786610844746