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

Published Washington, DC : National Academies Press, ©2007

Click on the following:
ProQuest Ebook Central

Copies

Description 1 online resource (xii, 332 pages) : illustrations Contents 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 Summary 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 Bibliography Includes bibliographical references and index Notes English Print version record Subject United States. Food and Drug Administration. SUBJECT United States Food and Drug Administration United States. Food and Drug Administration fast Subject Pharmaceutical policy -- United States Drugs -- United States -- Safety measures Drug Approval United States Government Agencies POLITICAL SCIENCE -- Public Policy -- Social Security. POLITICAL SCIENCE -- Public Policy -- Social Services & Welfare. Drugs -- Safety measures Pharmaceutical policy SUBJECT United States https://id.nlm.nih.gov/mesh/D014481 Subject United States Form Electronic book Author Baciu, Alina. Stratton, Kathleen R. Burke, Sheila P. ISBN 9780309665971 0309665973 9786610844746 6610844747

  Permalink