The Institute of Medicine's Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs presents this report, commissioned by the Food and Drug Administration, which proposes that the FDA embrace a lifecycle approach to drug safety oversight that would require an anticipatory role in shaping the directions of safety research, starting at the time of drug approval and continuing through the drug's market lifetime. It recommends that the FDA adopt a decision framework for evaluating benefit-risk information that addresses scientific and ethical disagreements and public values and that it create a single, publicly available document to track its oversight of each drug across its lifecycle. The report discusses the need for the FDA to adopt a consistent process for factoring different evidence in the making of regulatory decisions through the drug's lifecycle, challenges in evidence and decision-making, and the ability to require different types of postmarketing studies. No index is supplied. Annotation ©2012 Book News, Inc., Portland, OR (booknews.com)