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