Senate bill seeks to speed approvals of 'breakthrough therapies'

Sens. Michael Bennet (D-Colo.), Orrin Hatch (R-Utah) and Richard Burr (R-N.C.) introduced the Advancing Breakthrough Therapies for Patients Act, which would expedite FDA approval of "breakthrough" products that show "dramatic responses" early in development. The bill defines breakthrough therapies as those intended for a serious or life-threatening disease or condition where preliminary clinical evidence indicates that they may demonstrate substantial improvement over existing therapies. ...