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| n |
PGx will “help
individualize therapy with the
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intent of
maximizing effectiveness and
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minimizing risk.”
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| n |
Important “that
FDA policy facilitate, not
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impede,
the use of pharmacogenomic tests
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during drug
development and, to the extent
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possible,
encourage open and public sharing
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of data…on PGx
test results.”
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| n |
“most
experimental results may not be well
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enough
established to be suitable for
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regulatory
decision making”
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