Title Ethical and scientific issues in studying the safety of approved drugs / Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs, Board on Population Health and Public Health Practice, Institute of Medicine of the National Academies

Published Washington, D.C. : National Academies Press, ©2012

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Description 1 online resource (xvi, 275 pages) : illustrations Series Online access: National Academy of Sciences National Academies Press Online access: NCBI NCBI Bookshelf Contents Introduction -- Incorporating benefit and risk assessment and benefit-risk management into food and drug administration decision-making -- Evidence and decision-making -- Selection and oversight of required postmarketing studies -- Synthesis -- Appendixes Summary "An estimated 48 percent of the population takes at least one prescription drug in a given month. Drugs provide great benefits to society by saving or improving lives. Many drugs are also associated with side effects or adverse events, some serious and some discovered only after the drug is on the market. The discovery of new adverse events in the postmarketing setting is part of the normal natural history of approved drugs, and timely identification and warning about drug risks are central to the mission of the Food and Drug Administration (FDA). Not all risks associated with a drug are known at the time of approval, because safety data are collected from studies that involve a relatively small number of human subjects during a relatively short period. Written in response to a request by the FDA, Ethical and Scientific Issues in Studying the Safety of Approved Drugs discusses ethical and informed consent issues in conducting studies in the postmarketing setting. It evaluates the strengths and weaknesses of various approaches to generate evidence about safety questions, and makes recommendations for appropriate followup studies and randomized clinical trials. The book provides guidance to the FDA on how it should factor in different kinds of evidence in its regulatory decisions. Ethical and Scientific Issues in Studying the Safety of Approved Drugs will be of interest to the pharmaceutical industry, patient advocates, researchers, and consumer groups"--Publisher's description Notes Title screen viewed on Sept. 24, 2012 Bibliography Includes bibliographical references and index Notes English Subject Drugs -- Testing -- Moral and ethical aspects -- United States Drug approval -- United States Clinical trials -- Moral and ethical aspects -- United States Drug Evaluation -- ethics Clinical Trials as Topic -- ethics Drug Approval Product Surveillance, Postmarketing -- methods BUSINESS & ECONOMICS -- Business Ethics. Clinical trials -- Moral and ethical aspects Drug approval Drugs -- Testing -- Moral and ethical aspects SUBJECT United States Subject United States Genre/Form dissertations. Academic theses Academic theses. Thèses et écrits académiques. Form Electronic book Author Institute of Medicine (U.S.). Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs. LC no. 2012021854 ISBN 9780309218146 0309218144 0309218160 9780309218160

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