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Medical News and Perspectives
January 7, 2004

FDA Seeks Genome-Based Drug Data

JAMA. 2004;291(1):32-33. doi:10.1001/jama.291.1.32

Now that the human genome has been sequenced, the challenge ahead is to translate the information into clinical utility. Enter the field of pharmacogenomics—where information from individuals' DNA sequence variations is used to tailor drug treatments for patients—and the Food and Drug Administration (FDA).

The FDA has now issued a draft of a guidance document for drug companies that encourages them to conduct pharmacogenomic tests during drug development and to submit resulting data to the agency (http://www.fda.gov/cder/guidance/5900dft.pdf). The goal is to promote research that fine-tunes therapies so that each patient gets as much benefit as possible with the fewest adverse effects .

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