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

Committee on the Assessment of the US Drug Safety System (Author), Alina Baciu (Editor), Kathleen Stratton (Editor), Sheila P. Burke (Editor)

Book Description

ISBN-10: 0309103045 | ISBN-13: 978-0309103046 | Publication Date: February 28, 2007 | Edition: 1

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.

Editorial Reviews

Book 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.

About the Author

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

Product Details

• Paperback: 348 pages
• Publisher: National Academies Press; 1 edition (February 28, 2007)
• Language: English
• ISBN-10: 0309103045
• ISBN-13: 978-0309103046
• Product Dimensions: 8.8 x 6 x 0.8 inches
• Shipping Weight: 1.2 pounds (View shipping rates and policies)
• Amazon Best Sellers Rank: #2,092,598 in Books (See Top 100 in Books)