期刊
CLINICAL PHARMACOLOGY & THERAPEUTICS
卷 81, 期 2, 页码 294-297出版社
NATURE PUBLISHING GROUP
DOI: 10.1038/sj.clpt.6100053
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Drug developers have been using genomic information in drug development strategies for a number of years, but it was unclear how this information would be reviewed by the Food and Drug Administration (FDA). In order to evaluate the regulatory impact of genomic data in current drug development, a workshop was held in May 2002 to discuss aspects surrounding genomic data submission to the FDA (Figure 1).
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