“One Small Step”: The Food and Drug Administration and Pharmacogenomic Data

Food and Drug Administration. Guidance for Industry: Pharmacogenomic Data Submissions. US Department of Health and Human Services. Food and Drug Administration. Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research; Center for Devices and Radiological Health. November 2003. http://www.fda.gov/cber/gdlns/pharmdtasub.pdf. Accessed November 3, 2003.