Ethical and scientific issues in studying the safety of approved drugs

Corporate Author: Institute of Medicine (U.S.) Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs
Format: eBook
Published: Washington, D.C. National Academies Press 2012, c2012
Online Access:
Collection: National Center for Biotechnology Information - Collection details see MPG.ReNa
Table of Contents:
  • 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
  • Includes bibliographical references