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

Alina Baciu; Iom; Institute Of Medicine

Softcover

ISBN 10: 0309103045 ISBN 13: 9780309103046

Publisher: National Academy Press, 2007

Synopsis

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' riska "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 this title

About the Author

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

Edition details

• Publisher: National Academy Press
• Publication date: 2007
• Language: English
• ISBN 10: 0309103045
• ISBN 13: 9780309103046
• Binding: Paperback
• Edition number: 1
• Number of pages: 332