1. Center for Biologics Evaluation and Research; U.S. Food and Drug Administration; 1401 Rockville Pike, Suite 200N, HFM-1 Rockville MD 20852
2. Dr. Goodman's affiliation is provided for identification purposes. The views expressed in this book are those of the author and do not necessarily reflect those of the Food and Drug Administration or of the U.S. Department of Health and Human Services