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This situation has arisen because of the increasing number of exploratory and confirmatory investigations into variations in RNA expression patterns and DNA sequences being conducted in the preclinical and clinical phases of drug development, and the uncertainty surrounding the acceptance of these data by regulatory agencies. This report summarizes the outcome of a workshop cosponsored by the Food and Drug Administration (FDA), the Pharmacogenetics Working Group (PWG), the Pharmaceutical Research and Manufacturers of America (PhRMA), and the PhRMA Preclinical Safety Committee (DruSafe). The specific aim of the workshop was to identify key issues associated with the application of pharmacogenetics and pharmacogenomics, including the feasibility of a regulatory \u201csafe harbor\u201d for exploratory genome\u2010based data, and to provide a forum for industry\u2010regulatory agency dialogue on these important issues.<\/jats:p>","DOI":"10.1177\/0091270003252244","type":"journal-article","created":{"date-parts":[[2003,4,28]],"date-time":"2003-04-28T10:30:40Z","timestamp":1051525840000},"page":"342-358","source":"Crossref","is-referenced-by-count":100,"title":["Pharmacogenetics and Pharmacogenomics in Drug Development and Regulatory Decision Making: Report of the First FDA\u2010PWG\u2010PhRMA\u2010DruSafe Workshop"],"prefix":"10.1002","volume":"43","author":[{"given":"Lawrence J.","family":"Lesko","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ronald 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