NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were selected for their special competences and with regard for appropriate balance.

The Institute of Medicine was chartered in 1970 by the National Academy of Sciences to enlist distinguished members of the appropriate professions in the examination of policy matters pertaining to the health of the public. In this, the Institute acts under both the Academy's 1863 congressional charter responsibility to be an adviser to the federal government and its own initiative in identifying issues of medical care, research, and education. Dr. Kenneth I. Shine is president of the Institute of Medicine.

Support for this project was provided by the American Medical Association, Baxter International Inc., Eli Lilly, Food and Drug Administration (Center for Biologics Evaluation and Research, Center for Devices and Radiological Health, and Center for Drug Evaluation and Research), the Health Industry Manufacturers Association, Hoffmann-LaRoche, Merck & Co., Inc., National Institutes of Health (Office of Rare Diseases and National Institute of Child Health and Human Development), Pfizer, Pharmaceutical Research and Manufacturers of America, and Wyeth-Ayerst. The views presented are those of the Institute of Medicine's Roundtable on Research and Development of Drugs, Biologics, and Medical Devices and are not necessarily those of the funding organizations.

For information about the Institute of Medicine, visit the IOM home page at http://www.national-academies.org.

The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The image adopted as a logotype by the Institute of Medicine is based on a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin.