Published October 22, 2013 by OSP
There is one certainty about the current regulatory process for drug approval in the United States and Europe: No one likes it. Can this process be altered? Yes, but it will require a true reinvention of the regulatory drug-review process that addresses all of the flawed assumptions that exist with the current framework. One potential solution is adaptive licensing (also called “staggered approval” and “progressive licensing”), a novel approach that is currently being discussed by manufacturers, regulators, and other stakeholders.