Monday, November 24, 1997
WASHINGTON - President Clinton signed the FDA Modernization Act of 1997
on Friday, setting in motion a series of reforms and new time schedules that could provide
biotechnology companies with new options for getting products to market more rapidly and
for promoting them, as well as providing confidence that FDA will act more consistently.
But although the law and associated changes in FDA's user fee
commitments have been three years in the making, most top industry executives have just
started thinking about how they can take strategic advantage of them, and lawyers are just
beginning to map out the new regulatory landscape.