Accelerating adaptation

Thanks in 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...