Monday, June 23, 2014
large part to differences in the ways access to approved drugs are managed in
the European and the U.S. healthcare systems, EMA has
leapfrogged FDA with a pilot program on adaptive
licensing that would allow companies to market new products for limited
populations based on promising but early data.
On June 6,
EMA announced it had selected two undisclosed programs to participate in the
pilot out of nine applications the agency has reviewed. Four of the nine
applications are still candidates, and three were denied. Eleven more have yet
to be reviewed.