The Future of Drug Safety: Promoting and Protecting the Health of the Public

The Future of Drug Safety: Promoting and Protecting the Health of the Public

by Committee on the Assessment of the US Drug Safety System, Alina Baciu, Kathleen Stratton, Sheila P. Burke
     
 

ISBN-10: 0309103045

ISBN-13: 9780309103046

Pub. Date: 02/28/2007

Publisher: National Academies Press

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

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Overview

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' riskâ€"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.

Product Details

ISBN-13:
9780309103046
Publisher:
National Academies Press
Publication date:
02/28/2007
Pages:
348
Product dimensions:
6.00(w) x 9.00(h) x 0.80(d)

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