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NOTICE: The project that is the subject of this workshop summary 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 Roundtable responsible for the workshop summary were selected for their special competences and with regard for appropriate balance.

Support for this project was provided by the American Medical Association; Baxter International, Inc.; Eli Lilly; the U.S. 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-La Roche; Merck & Co., Inc.; National Institutes of Health (Office of Rare Diseases and National Institute of Child Health and Human Development); Pfizer; and Wyeth-Ayerst. The views presented are those of the authors and are not necessarily those of the funding organizations.

This report is based on the proceedings of a workshop that was sponsored by the Roundtable on Research and Development of Drugs, Biologics, and Medical Devices. It is prepared in the form of a workshop summary by and in the name of the editor with the assistance of staff and consultants, as an individually authored document. Sections of the workshop summary not specifically attributed to an individual reflect the views of the editor and not those of the Roundtable on Research and Development of Drugs, Biologics, and Medical Devices. The content of those sections is based on the presentations and the discussions that took place during the workshop.

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